NDC Code(s) : 0904-5553-61, 0904-5554-61
Packager : Major Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FAMOTIDINEFAMOTIDINE TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-5553
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE20 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
HYPROMELLOSE(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code C119
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-5553-61100 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075718 06/10/2009
FAMOTIDINEFAMOTIDINE TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-5554
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE40 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
HYPROMELLOSE 2208 (15000 CPS)(UNII: Z78RG6M2N2)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code C120
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-5554-61100 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075718 06/10/2009

PRINCIPAL DISPLAY PANEL

Famotidine 20 mg TabletsFamotidine 20 mg Tablets Famotidine 20 mg TabletsFamotidine 40 mg Tablets