Doxycycline hyclate tablet, delayed release

Ingredients and appearance - Product information

Doxycycline hyclate tablet, delayed release- Doxycycline hyclate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0115-1208
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Doxycycline hyclate ( UNII: 19XTS3T51U)( Doxycycline anhydrous - UNII: 334895S862 ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Sodium chloride ( UNII: 451W47IQ8X)
Talc ( UNII: 7SEV7J4R1U)
Hypromelloses ( UNII: 3NXW29V3WO)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Starch, corn ( UNII: O8232NY3SJ)
Crospovidone ( UNII: 2S7830E561)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color WHITE (off-white) Imprint Code F;91
Score 2 Shape OVAL (oval scored tablets containing yellow pellets)
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0115-1208-03 1000 in 1 BOTTLE 2011/04/11
2 NDC: 0115-1208-08 30 in 1 BOTTLE 2011/04/11
3 NDC: 0115-1208-13 60 in 1 BOTTLE 2011/04/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090505 USA 2011/04/11

Doxycycline hyclate tablet, delayed release- Doxycycline hyclate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0115-1209
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Doxycycline hyclate ( UNII: 19XTS3T51U)( Doxycycline anhydrous - UNII: 334895S862 ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Sodium chloride ( UNII: 451W47IQ8X)
Talc ( UNII: 7SEV7J4R1U)
Hypromelloses ( UNII: 3NXW29V3WO)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Starch, corn ( UNII: O8232NY3SJ)
Crospovidone ( UNII: 2S7830E561)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color WHITE (off-white) Imprint Code F;92
Score 2 Shape OVAL (oval scored tablets containing yellow pellets)
Size 15 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0115-1209-01 100 in 1 BOTTLE 2011/04/11
2 NDC: 0115-1209-03 1000 in 1 BOTTLE 2011/04/11
3 NDC: 0115-1209-08 30 in 1 BOTTLE 2011/04/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090505 USA 2011/04/11

Labeler - Impax Generics( 079832487)

Doxycycline has been found to be active against the asexual erythrocytic forms of Plasmodium falciparum but not against the gametocytes of P. falciparum. The precise mechanism of action of the drug is not known.
Organisms susceptible to tetracycline are also considered susceptible to doxycycline. However, some organisms that are intermediate or resistant to tetracycline may be susceptible to doxycycline.
The current absence of resistance isolates precludes defining any results other than "Susceptible". If isolates yielding MIC results other than susceptible, they should be submitted to a reference laboratory for further testing.
Gonococci with 30 mcg tetracycline disk zone diameters of less than 19 mm usually indicate a plasmid-mediated tetracycline resistant Neisseria gonorrhoeae isolate. Resistance in these strains should be confirmed by a dilution test (MIC greater than or equal to 16 mcg/mL).