Mycophenolate mofetil capsule

Warning

Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use mycophenolate mofetil. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Female users of childbearing potential must use contraception. Use of mycophenolate mofetil during pregnancy is associated with increased risk of pregnancy loss and congenital malformations.

Description

Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.

The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:

mycophenolate mofetil

Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group.

Mycophenolate mofetil hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1.

Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of mycophenolate mofetil, and tablets containing 500 mg of mycophenolate mofetil.

Inactive ingredients in mycophenolate mofetil 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-30), microcrystalline cellulose. The capsule shells contain yellow iron oxide, FD&C red # 3, gelatin, sodium lauryl sulfate, and titanium dioxide.

Inactive ingredients in mycophenolate mofetil 500 mg tablets include microcrystalline cellulose, croscarmellose sodium, povidone [K-30], magnesium stearate (Vegetable) and opadry brown.

The opadry brown contains FD & C blue #1 aluminum lake, FD & C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide.

Clinical pharmacology

Mechanism of action

Mycophenolate mofetil has been demonstrated in experimental animal models to prolong the survival of allogeneic transplants (kidney, heart, liver, intestine, limb, small bowel, pancreatic islets, and bone marrow).

Mycophenolate mofetil has also been shown to reverse ongoing acute rejection in the canine renal and rat cardiac allograft models. Mycophenolate mofetil also inhibited proliferative arteriopathy in experimental models of aortic and cardiac allografts in rats, as well as in primate cardiac xenografts. Mycophenolate mofetil was used alone or in combination with other immunosuppressive agents in these studies. Mycophenolate mofetil has been demonstrated to inhibit immunologically mediated inflammatory responses in animal models and to inhibit tumor development and prolong survival in murine tumor transplant models.

Mycophenolate mofetil is rapidly absorbed following oral administration and hydrolyzed to form MPA, which is the active metabolite. MPA is a potent, selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways, MPA has potent cytostatic effects on lymphocytes. MPA inhibits proliferative responses of T- and B-lymphocytes to both mitogenic and allospecific stimulation. Addition of guanosine or deoxyguanosine reverses the cytostatic effects of MPA on lymphocytes. MPA also suppresses antibody formation byB-lymphocytes. MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Mycophenolate mofetil did not inhibit early events in the activation of human peripheral blood mononuclear cells, such as the production of interleukin-1 (IL-1) and interleukin-2 (IL-2), but did block the coupling of these events to DNA synthesis and proliferation.

Pharmacokinetics

Following oral and intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to MPA, the active metabolite. Oral absorption of the drug is rapid and essentially complete. MPA is metabolized to form the phenolic glucuronide of MPA (MPAG) which is not pharmacologically active. The parent drug, mycophenolate mofetil, can be measured systemically during the intravenous infusion; however, shortly (about 5 minutes) after the infusion is stopped or after oral administration, MMF concentration is below the limit of quantitation (0.4 mcg/mL).

Clinical studies

Indications and usage

Contraindications

Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. Mycophenolate mofetil Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).

Warnings

(see boxed WARNING)

Precautions

Laboratory tests

Complete blood counts should be performed weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year (see WARNINGS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION ).

Drug interactions

Drug interaction studies with mycophenolate mofetil have been conducted with acyclovir, antacids, cholestyramine, cyclosporine, ganciclovir, oral contraceptives, sevelamer, trimethoprim/sulfamethoxazole, norfloxacin, and metronidazole. Drug interaction studies have not been conducted with other drugs that may be commonly administered to renal, cardiac or hepatic transplant patients. Mycophenolate mofetil has not been administered concomitantly with azathioprine.

Pregnancy

Teratogenic Effects: Pregnancy Category D. See WARNINGSsection.

Nursing mothers

Studies in rats treated with mycophenolate mofetil have shown mycophenolic acid to be excreted in milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from mycophenolate mofetil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

Based on pharmacokinetic and safety data in pediatric patients after renal transplantation, the recommended dose of mycophenolate mofetil oral suspension is 600 mg/m 2bid (up to maximum of 1 g bid). Also see CLINICAL PHARMACOLOGY, CLINICAL STUDIES, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION.

Safety and effectiveness in pediatric patients receiving allogenic cardiac or hepatic transplants have not been established.

Geriatric use

Clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant or other drug therapy. Elderly patients may be at an increased risk of adverse reactions compared with younger individuals (see ADVERSE REACTIONS ).

Adverse reactions

The principal adverse reactions associated with the administration of mycophenolate mofetil include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections eg, opportunistic infection (see WARNINGS: Infections and WARNINGS: Latent Viral Infections ). The adverse event profile associated with the administration of mycophenolate mofetil Intravenous has been shown to be similar to that observed after administration of oral dosage forms of mycophenolate mofetil.

Overdosage

The experience with overdose of mycophenolate mofetil in humans is very limited. The events received from reports of overdose fall within the known safety profile of the drug. The highest dose administered to renal transplant patients in clinical trials has been 4 g/day. In limited experience with cardiac and hepatic transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, principally neutropenia, leading to a need to reduce or discontinue dosing.

In acute oral toxicity studies, no deaths occurred in adult mice at doses up to 4000 mg/kg or in adult monkeys at doses up to 1000 mg/kg; these were the highest doses of mycophenolate mofetil tested in these species. These doses represent 11 times the recommended clinical dose in renal transplant patients and approximately 7 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In adult rats, deaths occurred after single-oral doses of 500 mg/kg of mycophenolate mofetil. The dose represents approximately 3 times the recommended clinical dose in cardiac transplant patients when corrected for BSA.

MPA and MPAG are usually not removed by hemodialysis. However, at high MPAG plasma concentrations (>100 mcg/mL), small amounts of MPAG are removed. By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine (see CLINICAL PHARMACOLOGY: Pharmacokinetics ).

Dosage and administration

How supplied

Mycophenolate mofetil capsules, 250 mg

White to off-white colored free flowing powder filled in size 1 hard gelatin capsule with Ivory Cap and Ivory Body, printed SAL on cap and 726 on body in black. Supplied in the following presentations:

NDC Number Size

NDC 59762-0703-1 Bottle of 100

NDC 59762-0703-2 Bottle of 120

NDC 59762-0703-3 Bottle of 500

Storage

Store at 20- 25C (68-77F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturers original containers.

Mycophenolate mofetil tablets, 500 mg

Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations:

NDC Number Size

NDC 59762-0702-1 Bottle of 100

NDC 59762-0702-3 Bottle of 500

Storage and Dispensing Information

Store at 20- 25C (68-77F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturers original containers.

Made in India

greenstone logo

Distributed by:

Greenstone LLC

Peapack, NJ 07977

Revised: June 2010

1014373

Spl medguide

MEDICATION GUIDE

mycophenolate mofetil capsules

mycophenolate mofetil tablets

Read the Medication Guide that comes with mycophenolate mofetil before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about mycophenolate mofetil?

Mycophenolate mofetil can cause serious side effects:

  • Possible loss of a pregnancy and higher risk of birth defects. Women who take mycophenolate mofetil during pregnancy have a higher risk of losing a pregnancy (miscarriage) during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects

If you are a female and are able to become pregnant

  • Your healthcare provider must talk with you about effective birth control methods (contraceptive counseling)
  • You should have a negative pregnancy test within 1 week before you start to take mycophenolate mofetil
  • You must use 2 different types of effective birth control at the same time, for 4 weeks before you start taking mycophenolate mofetil, during your entire mycophenolate mofetil therapy and for 6 weeks after stopping mycophenolate mofetil, unless you choose to avoid sexual intercourse completely (abstinence). Mycophenolate mofetil decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take mycophenolate mofetil, and you could become pregnant

If you plan to become pregnant, talk with your healthcare provider. Your healthcare provider will decide if other medicines to prevent rejection may be right for you. In certain situations, you and your healthcare provider may decide that taking mycophenolate mofetil is more important to your health than the possible risks to your unborn baby.

  • If you get pregnant while taking mycophenolate mofetil, do not stop taking mycophenolate mofetil. Call your healthcare provider right away.You and your healthcare provider should report any cases of pregnancies to
  • FDA Med Watch at 1-800-FDA-1088
  • Greenstone LLC Professional Drug safety at 1-800-438-1985

Talk to your healthcare provider about joining the National Transplantation Pregnancy Registry at 1-877-955-6877.

  • Increased risk of getting serious infections. Mycophenolate mofetil weakens the bodys immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil and can lead to death. Types of infections can include:
  • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with mycophenolate mofetil include:
  • Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.
  • BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail.
  • A brain infection called Progressive Multifocal Leukoencephalopathy (PML).In some patients, mycophenolate mofetil may cause an infection of the brain that may cause death. You are at risk for this brain infection because you have a weakened immune system. You should tell your healthcare provider right away if you have any of the following symptoms:
  • Weakness on one side of the body
  • You do not care about things that you usually care about (apathy)
  • You are confused or have problems thinking
  • You can not control your muscles
  • Fungal infections.Yeasts and other types of fungal infections can happen with mycophenolate mofetil and can cause serious tissue and blood infections (see " What are the possible side effects of mycophenolate mofetil?")

Call your healthcare provider right away if you have any of the following signs and symptoms of infection:

  • Temperature of 100.5F or greater
  • Cold symptoms, such as a runny nose or sore throat
  • Flu symptoms, such as an upset stomach, stomach pain, vomiting or diarrhea
  • Earache or headache
  • Pain during urination
  • White patches in the mouth or throat
  • Unexpected bruising or bleeding
  • Cuts, scrapes or incisions that are red, warm and oozing pus
  • Increased risk of getting certain cancers.People who take mycophenolate mofetil have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your healthcare provider if you have:
  • unexplained fever, prolonged tiredness, weight loss or lymph node swelling
  • a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other
  • a change in the size and color of a mole
  • a new skin lesion or bump
  • any other changes to your health

See the section "What are the possible side effects of mycophenolate mofetil?" for information about other serious side effects.

What is mycophenolate mofetil?

Mycophenolate mofetil is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Rejection is when the bodys immune system perceives the new organ as a "foreign" threat and attacks it.

Mycophenolate mofetil is used with other medicines called cyclosporines (Sandimmune ®, Gengrat ®, Neoral ®) and corticosteroids. These medicines work together to prevent rejection to your transplanted organ.

Mycophenolate mofetil has been used safely and works in children who received a kidney transplant as it does in adults. It is not known if mycophenolate mofetil is safe and works in children who receive a heart or liver transplant.

Who should not take mycophenolate mofetil?

Do not take mycophenolate mofetil if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil capsules and tablets. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil capsules and tablets.

What should I tell my healthcare provider before taking mycophenolate mofetil?

Tell your healthcare provider about all of your medical conditions, if you:

  • have any digestive problems, such as ulcers
  • have Phenylketonuria (PKU).
  • have Lesch-Nyhan or Kelley-Seegmifier syndrome or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT).You should not take mycophenolate mofetil if you have one of these disorders
  • plan to receive any vaccines. People taking mycophenolate mofetil should not take live vaccines.Some vaccines may not work as well during treatment with mycophenolate mofetil
  • are pregnant or are planning to become pregnant See "What is the most important information I should know about mycophenolate mofetil?"
  • are breastfeeding. It is not known if mycophenolate mofetil passes into breast milk. You and your healthcare provider will decide if you will take mycophenolate mofetil or breastfeed. You should not do both without first talking with your healthcare provider

Tell your healthcare provider about all of the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines may affect the way mycophenolate mofetil works, and mycophenolate mofetil may affect how some medicines work. Especially tell your healthcare provider if you take:

  • birth control pills (oral contraceptives). See " What is the most important information I should know about mycophenolate mofetil?"
  • sevelamer (Renagel ®, Renvela TM). These products should be taken 2 hours after taking mycophenolate mofetil
  • acyclovir (Zovirax ®), valacyclovir (Valtrex ®), ganciclovir (Cytovene ®-IV, Vitrasert) Valgancyclovir (Valcyte ®)
  • rifampin (Rifater ®, Rifamate ®, Rimactane ®, Rifadin ®)
  • antacids that contain magnesium and aluminum (mycophenolate mofetil and the antacid should not be taken at the same time)
  • sulfamethoxazole/trimethoprim (Bactrim TM, Bactrim DS TM)
  • norfioxacin (Noroxin ®) and metronidazole (Flagyl ®, Flagyl ®ER, Flagyl ®IV, Metro IV, Helidac , Pylera TM)
  • ciprofloxacin (Cipro ®, Cipro ®XR, Ciloxan ®, Proquin ®XR) and amoxicillin plus clavulanic acid (Augmentin ®, Augmentin XR™)
  • azathioprine (Azasan ®, Imuran ®)
  • cholestyramine (Questran Light ®, Questran ®, Locholest Light, Locholest, Prevalite ®)

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. Do not take any new medicine without talking with your healthcare provider.

How should I take mycophenolate mofetil?

  • Take mycophenolate mofetil exactly as prescribed
  • Do not stop taking mycophenolate mofetil or change the dose unless your healthcare provider tells you to
  • If you miss a dose of mycophenolate mofetil, or are not sure when you took your last dose, take the regular amount of mycophenolate mofetil prescribed as soon as you remember. If it is time for your next dose, skip the missed dose. Do not take 2 doses at the same time. Call your healthcare provider if you are not sure what to do
  • Take mycophenolate mofetil capsules and tablets on an empty stomach, either 1 hour before or 2 hours after a meal, unless your healthcare provider tells you otherwise. With the approval of your healthcare provider, in stable kidney transplant patients, mycophenolate mofetil can be taken with food if necessary
  • Most people take mycophenolate mofetil by mouth as ivory capsules or pinkish brown tablets. Some people may get mycophenolate mofetil soon after their transplant surgery as an infusion into a vein
  • Do not crush mycophenolate mofetil tablets. Do not open or crush mycophenolate mofetil capsules
  • If you take too much mycophenolate mofetil, call your healthcare provider or the poison control center right away

What should I avoid while taking mycophenolate mofetil?

  • Avoid pregnancy. See "What is the most important information I should know about mycophenolate mofetil?"
  • Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take mycophenolate mofetil have a higher risk of getting skin cancer. (See "What is the most important information I should know about mycophenolate mofetil?")Wear protective clothing when you are in the sun and use a sunscreen with a high protection factor (SPF 30 and above). This is especially important if your skin is very fair or if you have a family history of skin cancer

What are the possible side effects of mycophenolate mofetil?

Mycophenolate mofetil can cause serious side effects:

  • See "What is the most important information I should know about mycophenolate mofetil?"
  • Low blood cell counts.People taking high doses of mycophenolate mofetil each day may have a decrease in blood counts, including
  • White blood cells, especially neutrophils.Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 3 months to 6 months after your transplant
  • red blood cells.Red blood cells carry oxygen to your body tissues. You have higher chances of getting severe anemia when your red blood cell count is low
  • platelets.Platelets help with blood clotting

Your healthcare provider will do blood tests before you start taking mycophenolate mofetil and during treatment with mycophenolate mofetil to check your blood cell counts.

Tell your healthcare provider right away if you have any signs of infection (see "What is the most important information I should know about mycophenolate mofetil?").Also, tell your healthcare provider about any unexpected bruising or bleeding. Also, tell your healthcare provider if you have unusual tiredness, lack of energy, dizziness or fainting.

  • Stomach problems.Stomach and intestinal bleeding can happen in people who take high doses of mycophenolate mofetil. Bleeding can be severe and you may have to be hospitalized for treatment
  • Common side effects include:
  • diarrhea. Call your healthcare provider right away if you have diarrhea. Do not stop taking mycophenolate mofetil without first talking with your healthcare provider
  • vomiting
  • pain
  • stomach area pain
  • swelling of the lower legs, ankles and feet
  • high blood pressure
  • Side effects that happen more often in children than in adults taking mycophenolate mofetil include:
  • stomach area pain
  • sore throat
  • fever
  • colds (respiratory tract infections)
  • infection
  • high blood pressure
  • pain
  • low white blood cell count
  • blood infection (sepsis)
  • Low red blood cell count
  • diarrhea
  • vomiting

These are not all of the possible side effects of mycophenolate mofetil. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA- 1088 or to Greenstone LLC Professional Drug Safety at 1.800.438.1985.

How should I store mycophenolate mofetil?

  • Store at 20- 25C (68-77F). {See USP controlled room temperature}. Keep the container closed tightly
  • Keep mycophenolate mofetil and all medicines out of the reach of children

General Information about mycophenolate mofetil

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for a condition for which it was not prescribed. Do not give mycophenolate mofetil to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about mycophenolate mofetil. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil that is written for healthcare professionals.

What are the ingredients in mycophenolate mofetil?

Active Ingredient:mycophenolate mofetil

Inactive Ingredients:

Mycophenolate mofetil 250 mg capsules:croscarmellose sodium, magnesium stearate, povidone (K-30) and microcrystalline cellulose. The capsule shells contain yellow iron oxide, FD&C red # 3, gelatin, sodium lauryl sulfate, and titanium dioxide.

Mycophenolate mofetil 500 mg tablets:microcrystalline cellulose, croscarmellose sodium, povidone [K-30], magnesium stearate (Vegetable) and opadry brown.The opadry brown contains FD & C blue #1 aluminum lake, FD & C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide.

This Medication Guide has been approved by the US Food and Drug Administration.

Made in India

greenstone logo

Distributed by:

Greenstone LLC

Peapack, NJ 07977

Revised: June 2010

Ingredients and appearance - Product information

Mycophenolate mofetil tablet, film coated- Mycophenolate mofetil

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 59762-0702
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Mycophenolate mofetil ( UNII: 9242ECW6R0)( Mycophenolic acid - UNII: HU9DX48N0T ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Ferric oxide red ( UNII: 1K09F3G675)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Titanium dioxide ( UNII: 15FIX9V2JP)
Povidone k30 ( UNII: U725QWY32X)
Microcrystalline cellulose ( UNII: OP1R32D61U)

Product Characteristics

Color BROWN Score 1
Shape CAPSULE Size 18 mm
Imprint Code SAL725

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 59762-0702-1 100 in 1 BOTTLE, PLASTIC 2010/06/11
2 NDC: 59762-0702-3 500 in 1 BOTTLE, PLASTIC 2010/06/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090456 USA 2010/06/11

Mycophenolate mofetil capsule- Mycophenolate mofetil

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 59762-0703
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Mycophenolate mofetil ( UNII: 9242ECW6R0)( Mycophenolic acid - UNII: HU9DX48N0T ) 250 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Ferric oxide red ( UNII: 1K09F3G675)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Titanium dioxide ( UNII: 15FIX9V2JP)
Povidone k30 ( UNII: U725QWY32X)
Microcrystalline cellulose ( UNII: OP1R32D61U)

Product Characteristics

Color WHITE Score 1
Shape CAPSULE Size 1 mm
Imprint Code SAL726

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 59762-0703-1 100 in 1 BOTTLE, PLASTIC 2010/06/11
2 NDC: 59762-0703-2 120 in 1 BOTTLE, PLASTIC 2010/06/11
3 NDC: 59762-0703-3 500 in 1 BOTTLE, PLASTIC 2010/06/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090055 USA 2010/06/11

Labeler - Greenstone LLC( 825560733)

Establishment

Name ID/FEI Business Operations
Greenstone LLC 825560733 MANUFACTURE( 59762-0702, 59762-0703)

Package label.principal display panel

Package label.principal display panel