Metoclopramide tablet

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Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.

Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.



For oral administration, metoclopramide tablets, USP 10 mg are white to off white, capsule shaped, biconvex tablets with "P31" debossed on one side and score line on the other side.

Each tablet contains:

10 mg of metoclopramide base as metoclopramide hydrochloride, USP

Clinical pharmacology

Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its mode of action is unclear. It seems to sensitize tissues to the action of acetylcholine. The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs.

Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter. It has little, if any, effect on the motility of the colon or gallbladder.

In patients with gastroesophageal reflux and low LESP (lower esophageal sphincter pressure), single oral doses of metoclopramide produce dose-related increases in LESP. Effects begin at about 5 mg and increase through 20 mg (the largest dose tested). The increase in LESP from a 5 mg dose lasts about 45 minutes and that of 20 mg lasts between 2 and 3 hours. Increased rate of stomach emptying has been observed with single oral doses of 10 mg.

The antiemetic properties of metoclopramide appear to be a result of its antagonism of central and peripheral dopamine receptors. Dopamine produces nausea and vomiting by stimulation of the medullary chemoreceptor trigger zone (CTZ), and metoclopramide blocks stimulation of the CTZ by agents like l-dopa or apomorphine which are known to increase dopamine levels or to possess dopamine-like effects. Metoclopramide also abolishes the slowing of gastric emptying caused by apomorphine.

Like the phenothiazines and related drugs, which are also dopamine antagonists, metoclopramide produces sedation and may produce extrapyramidal reactions, although these are comparatively rare (see WARNINGS).Metoclopramide inhibits the central and peripheral effects of apomorphine, induces release of prolactin and causes a transient increase in circulating aldosterone levels, which may be associated with transient fluid retention.

The onset of pharmacological action of metoclopramide is 1 to 3 minutes following an intravenous dose, 10 to 15 minutes following intramuscular administration, and 30 to 60 minutes following an oral dose; pharmacological effects persist for 1 to 2 hours.


Metoclopramide is rapidly and well absorbed. Relative to an intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide is 80% 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occur at about 1 to 2 hr after a single oral dose. Similar time to peak is observed after individual doses at steady state.

In a single dose study of 12 subjects, the area under the drug concentration-time curve increases linearly with doses from 20 to 100 mg. Peak concentrations increase linearly with dose; time to peak concentrations remains the same; whole body clearance is unchanged; and the elimination rate remains the same. The average elimination half-life in individuals with normal renal function is 5 to 6 hr. Linear kinetic processes adequately describe the absorption and elimination of metoclopramide.

Approximately 85% of the radioactivity of an orally administered dose appears in the urine within 72 hr. Of the 85% eliminated in the urine, about half is present as free or conjugated metoclopramide.

The drug is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about 3.5 L/kg) which suggests extensive distribution of drug to the tissues.

Renal impairment affects the clearance of metoclopramide. In a study with patients with varying degrees of renal impairment, a reduction in creatinine clearance was correlated with a reduction in plasma clearance, renal clearance, non-renal clearance, and increase in elimination half-life. The kinetics of metoclopramide in the presence of renal impairment remained linear however. The reduction in clearance as a result of renal impairment suggests that adjustment downward of maintenance dosage should be done to avoid drug accumulation.

Adult Pharmacokinetic Data
t 1 / 2 (hr)

In pediatric patients, the pharmacodynamics of metoclopramide following oral and intravenous administration are highly variable and a concentration-effect relationship has not been established.

There are insufficient reliable data to conclude whether the pharmacokinetics of metoclopramide in adults and the pediatric population are similar. Although there are insufficient data to support the efficacy of metoclopramide in pediatric patients with symptomatic gastroesophageal reflux (GER) or cancer chemotherapy-related nausea and vomiting, its pharmacokinetics have been studied in these patient populations.

In an open-label study, six pediatric patients (age range, 3.5 weeks to 5.4 months) with GER received metoclopramide 0.15 mg/kg oral solution every 6 hours for 10 doses. The mean peak plasma concentration of metoclopramide after the tenth dose was 2-fold (56.8 g/L) higher compared to that observed after the first dose (29 g/L) indicating drug accumulation with repeated dosing. After the tenth dose, the mean time to reach peak concentrations (2.2 hr), half-life (4.1 hr), clearance (0.67 L/h/kg), and volume of distribution (4.4 L/kg) of metoclopramide were similar to those observed after the first dose. In the youngest patient (age, 3.5 weeks), metoclopramide half-life after the first and the tenth dose (23.1 and 10.3 hr, respectively) was significantly longer compared to other infants due to reduced clearance. This may be attributed to immature hepatic and renal systems at birth.

Single intravenous doses of metoclopramide 0.22 to 0.46 mg/kg (mean, 0.35 mg/kg) were administered over 5 minutes to 9 pediatric cancer patients receiving chemotherapy (mean age, 11.7 years; range, 7 to 14 yr) for prophylaxis of cytotoxic-induced vomiting. The metoclopramide plasma concentrations extrapolated to time zero ranged from 65 to 395 mcg/L (mean, 152 mcg/L).The mean elimination half-life, clearance, and volume of distribution of metoclopramide were 4.4 hr (range, 1.7 to 8.3 hr), 0.56 L/h/kg (range, 0.12 to 1.20 L/h/kg), and 3 L/kg (range, 1 to 4.8 L/kg), respectively.

In another study, nine pediatric cancer patients (age range, 1 to 9 yr) received 4 to 5 intravenous infusions (over 30 minutes) of metoclopramide at a dose of 2 mg/kg to control emesis. After the last dose, the peak serum concentrations of metoclopramide ranged from 1060 to 5680 mcg/L. The mean elimination half-life, clearance, and volume of distribution of metoclopramide were 4.5 hr (range, 2 to 12.5 hr), 0.37 L/h/kg (range, 0.10 to 1.24 L/h/kg), and 1.93 L/kg (range, 0.95 to 5.50 L/kg), respectively.

Indications and usage

The use of metoclopramide tablets, USP is recommended for adults only. Therapy should not exceed 12 weeks in duration.


Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation.

Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine.

Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug.

Metoclopramide should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.


Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.

Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide.These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly, and they usually will subside. Benztropine mesylate, 1 to 2 mg intramuscularly, may also be used to reverse these reactions.

Parkinsonian-like symptoms have occurred, more commonly within the first 6 months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuance of metoclopramide. Patients with preexisting Parkinsons disease should be given metoclopramide cautiously, if at all, since such patients may experience exacerbation of parkinsonian symptoms when taking metoclopramide.


Information for patients

The use of metoclopramide tablets is recommended for adults only. Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be cautioned accordingly.

For additional information, patients should be instructed to see the Medication Guide for metoclopramide tablets.

Drug interactions

The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers.

The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors.

Absorption of drugs from the stomach may be diminished (e.g., digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine).

Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment.

Nursing mothers

Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.

Pediatric use

Safety and effectiveness in pediatric patients have not been established (see OVERDOSAGE).

Care should be exercised in administering metoclopramide to neonates since prolonged clearance may produce excessive serum concentrations (see CLINICAL PHARMACOLOGY- Pharmacokinetics ). In addition, neonates have reduced levels of NADH-cytochrome b 5reductase which, in combination with the aforementioned pharmacokinetic factors, make neonates more susceptible to methemoglobinemia (see OVERDOSAGE ).

The safety profile of metoclopramide in adults cannot be extrapolated to pediatric patients. Dystonias and other extrapyramidal reactions associated with metoclopramide are more common in the pediatric population than in adults. (See WARNINGS and ADVERSE REACTIONS- Extrapyramidal Reactions .)

Geriatric use

Clinical studies of metoclopramide tablets did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.

The risk of developing parkinsonianlike side effects increases with ascending dose. Geriatric patients should receive the lowest dose of metoclopramide tablets that is effective. If parkinsonian-like symptoms develop in a geriatric patient receiving metoclopramide tablets, metoclopramide tablets should generally be discontinued before initiating any specific anti-parkinsonian agents (see WARNINGSand DOSAGE AND ADMINISTRATION For the Relief of Symptomatic Gastroesophageal Reflux ) .

The elderly may be at greater risk for tardive dyskinesia (see WARNINGS Tardive Dyskinesia ) .

Sedation has been reported in metoclopramide tablets users. Sedation may cause confusion and manifest as over-sedation in the elderly (see CLINICAL PHARMACOLOGY, PRECAUTIONS- Information for Patients and ADVERSE REACTIONS CNS Effects ).

Metoclopramide tablets are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see DOSAGE AND ADMINISTRATION- Use in Patients with Renal or Hepatic Impairment ).

For these reasons, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function, concomitant disease, or other drug therapy in the elderly (see DOSAGE AND ADMINISTRATION For the Relief of Symptomatic Gastroesophageal Reflux and Use in Patients with Renal or Hepatic Impairment ).

Adverse reactions

In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency:


Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. Symptoms are self-limiting and usually disappear within 24 hours.

Hemodialysis removes relatively little metoclopramide, probably because of the small amount of the drug in blood relative to tissues. Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of drug. It is unlikely that dosage would need to be adjusted to compensate for losses through dialysis. Dialysis is not likely to be an effective method of drug removal in overdose situations.

Unintentional overdose due to misadministration has been reported in infants and children with the use of metoclopramide oral solution. While there was no consistent pattern to the reports associated with these overdoses, events included seizures, extrapyramidal reactions, and lethargy.

Methemoglobinemia has occurred in premature and full-term neonates who were given overdoses of metoclopramide (1 to 4 mg/kg/day orally, intramuscularly or intravenously for 1 to 3 or more days). Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal (see PRECAUTIONS Other Special Populations).

Dosage and administration

Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

How supplied

Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "P31" debossed on one side and score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride, USP. Available in:

Bottle of 100 tablets NDC 69452-101-20

Bottle of 500 tablets NDC 69452-101-30

Bottle of 1000 tablets NDC 69452-101-32

Each white to off white, oval shaped biconvex tablets metoclopramide tablets, USP with "P32" debossed on one side and plain on the other side contains 5 mg of metoclopramide base as metoclopramide hydrochloride, USP. Available in:

Bottle of 100 tablets NDC 69452-100-20

Bottle of 500 tablets NDC 69452-100-30

Dispense tablets in tight, light-resistant container.

Store between 20 and 25 C (68 and 77 F) [See USP Controlled Room Temperature].

You may report side effects to FDA at 1-800-FDA-1088.

Spl unclassified section

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

by: Ipca Laboratories Limited

48, Kandivli Ind. Estate,

Mumbai 400 067, India.

February 2015

Spl medguide section


Metoclopramide Tablets, USP

Read the Medication Guide that comes with metoclopramide tablets before you start taking it and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection, metoclopramide orally disintegrating tablets, or metoclopramide oral syrup), you should read the Medication Guide that comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about metoclopramide tablets?

Metoclopramide tablets can cause serious side effects, including:

Tardive dyskinesia (abnormal muscle movements).These movements happen mostly in the face muscles. You can not control these movements. They may not go away even after stopping metoclopramide tablets. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking metoclopramide tablets.

Your chances for getting tardive dyskinesia go up:

  • the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You should not take metoclopramide tablets for more than 12 weeks.
  • if you are older, especially if you are a woman
  • if you have diabetes

It is not possible for your doctor to know if you will get tardive dyskinesia if you take metoclopramide tablets.

Call your doctor right away if you get movements you can not stop or control, such as:

  • lip smacking, chewing, or puckering up your mouth
  • frowning or scowling
  • sticking out your tongue
  • blinking and moving your eyes
  • shaking of your arms and legs

See the section "What are the possible side effects of metoclopramide tablets?" for more information about side effects.

What are metoclopramide tablets?

Metoclopramide tablets are a prescription medicine used:

  • in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain other treatments do not work. Metoclopramide tablets relieve daytime heartburn and heartburn after meals. It also helps ulcers in the esophagus to heal.
  • to relieve symptoms of slow stomach emptying in people with diabetes. Metoclopramide tablets help treat symptoms such as nausea, vomiting, heartburn, feeling full long after a meal, and loss of appetite. Not all these symptoms get better at the same time.

It is not known if metoclopramide tablets are safe and work in children.

Who should not take metoclopramide tablets?

Do not take metoclopramide tablets if you:

  • have stomach or intestine problems that could get worse with metoclopramide tablets, such as bleeding, blockage or a tear in the stomach or bowel wall
  • have an adrenal gland tumor called a pheochromocytoma
  • are allergic to metoclopramide tablets or anything in it. See the end of this Medication Guide for a list of ingredients in metoclopramide tablets.
  • take medicines that can cause uncontrolled movements, such as medicines for mental illness
  • have seizures

What should I tell my doctor before taking metoclopramide tablets?

Tell your doctor about all your medical conditions, including if you have:

  • depression
  • Parkinsons disease
  • high blood pressure
  • kidney problems. Your doctor may start with a lower dose.
  • liver problems or heart failure. Metoclopramide tablets may cause your body to hold fluids.
  • diabetes. Your dose of insulin may need to be changed.
  • breast cancer
  • you are pregnant or plan to become pregnant. It is not known if metoclopramide tablets will harm your unborn baby.
  • you are breast-feeding. Metoclopramide tablets can pass into breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you take metoclopramide tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.Metoclopramide tablets and some other medicines may interact with each other and may not work as well, or cause possible side effects. Do not start any new medicines while taking metoclopramide tablets until you talk with your doctor.

Especially tell your doctor if you take:

  • another medicine that contains metoclopramide, such as metoclopramide orally disintegrating tablets, or metoclopramide oral syrup
  • a blood pressure medicine
  • a medicine for depression, especially an Monoamine Oxidase Inhibitor (MAOI)
  • insulin
  • a medicine that can make you sleepy, such an anti-anxiety medicine, sleep medicines, and narcotics.

If you are not sure if your medicine is one listed above, ask your doctor or pharmacist.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take metoclopramide tablets?

  • Metoclopramide tablets come as a tablet you take by mouth.
  • Take metoclopramide tablets exactly as your doctor tells you. Do not change your dose unless your doctor tells you.
  • You should not take metoclopramide tablets for more than 12 weeks.
  • If you take too much metoclopramide tablets, call your doctor or Poison Control Center right away.

What should I avoid while taking metoclopramide tablets?

  • Do not drink alcohol while taking metoclopramide tablets. Alcohol may make some side effects of metoclopramide tablets worse, such as feeling sleepy.
  • Do not drive, work with machines, or do dangerous tasks until you know how metoclopramide tablets affect you. Metoclopramide tablets may cause sleepiness.

What are the possible side effects of metoclopramide tablets?

Metoclopramide tablets can cause serious side effects, including:

  • Tardive dyskinesia (abnormal muscle movements).See "What is the most important information I need to know about metoclopramide tablets?"
  • Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia).These muscle spasms can cause abnormal movements and body positions. These spasms usually start within the first 2 days of treatment. These spasms happen more often in children and adults under age 30.
  • Depression, thoughts about suicide, and suicide.Some people who take metoclopramide tablets become depressed. You may have thoughts about hurting or killing yourself. Some people who take metoclopramide tablets have ended their own lives (suicide).
  • Neuroleptic Malignant Syndrome (NMS).NMS is a very rare but very serious condition that can happen with metoclopramide tablets. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating.
  • Parkinsonism.Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinsons disease, your symptoms may become worse while you are receiving metoclopramide tablets.

Call your doctor and get medical help right away if you:

  • feel depressed or have thoughts about hurting or killing yourself
  • have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating
  • have muscle movements you cannot stop or control
  • have muscle movements that are new or unusual

Common side effects of metoclopramide tablets include:

  • feeling restless, sleepy, tired, dizzy, or exhausted
  • headache
  • confusion
  • trouble sleeping

You may have more side effects the longer you take metoclopramide tablets and the more metoclopramide tablets you take.

You may still have side effects after stopping metoclopramide tablets. You may have symptoms from stopping (withdrawal) metoclopramide tablets such as headaches, and feeling dizzy or nervous.

Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of metoclopramide tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800FDA-1088.

How should I store metoclopramide tablets?

  • Keep metoclopramide tablets at room temperature between 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature].
  • Keep metoclopramide tablets in the bottle it comes in. Keep the bottle closed tightly.

Keep metoclopramide tablets and all medicines out of the reach of children.

General information about metoclopramide tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use metoclopramide tablets for a condition for which it was not prescribed. Do not give metoclopramide tablets 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 metoclopramide tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about metoclopramide tablets that is written for health professionals.

To obtain the Medication Guide online please visit

What are the ingredients in metoclopramide tablets?

Active ingredient:metoclopramide hydrochloride, USP

Inactive ingredients:

Metoclopramide tablets, USP 10 mg:microcrystalline cellulose, corn starch, pregelatinized starch, colloidal silicon dioxide and stearic acid.

Metoclopramide tablets, USP 5 mg:microcrystalline cellulose, corn starch, pregelatinized starch, colloidal silicon dioxide and stearic acid.

Spl unclassified section

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

by: Ipca Laboratories Limited

48, Kandivli Ind. Estate,

Mumbai 400 067, India.

February 2015

Spl unclassified section

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

Ingredients and appearance - Product information

Metoclopramide tablet- Metoclopramide

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 69452-100
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Metoclopramide hydrochloride ( UNII: W1792A2RVD)( Metoclopramide - UNII: L4YEB44I46 ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color WHITE (off white) Shape OVAL
Size 9 mm Score 1
Imprint Code P;32

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date

Labeler - Bionpharma Inc.( 079637826)


Name ID/FEI Business Operations
Bionpharma Inc. 079637826 manufacture( 69452-100, 69452-101)

Package label.principal display panel

Bionpharma Inc.

NDC 69452-101-30


10 mg

PHARMACIST: Dispense the enclosed Medication Guide to each patient.*

Rx only

500 Tablets

Package label.principal display panel

Bionpharma Inc.

NDC 69452-100-30


5 mg

PHARMACIST: Dispense the enclosed Medication Guide to each patient.*

Rx only

500 Tablets