NDC Code(s) : 35356-730-30, 35356-730-60, 35356-730-90, 35356-926-30, 35356-926-60, 35356-926-90
Packager : Lake Erie Medical DBA Quality Care Products LLC

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:35356-730(NDC:64679-937)
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND (barrel shape) Size 9 mm
Flavor Imprint Code W;937
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-730-3030 in 1 BOTTLE Type 0: Not a Combination Product27/07/2012
2NDC:35356-730-6060 in 1 BOTTLE Type 0: Not a Combination Product27/07/2012
3NDC:35356-730-9090 in 1 BOTTLE Type 0: Not a Combination Product27/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075786 07/27/2012
FamotidineFamotidine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-926(NDC:64679-936)
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Product Characteristics
Color BROWN (beige) Score no score
Shape ROUND (barrel shape) Size 9 mm
Flavor Imprint Code W;936
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-926-3030 in 1 BOTTLE Type 0: Not a Combination Product16/04/2001
2NDC:35356-926-6060 in 1 BOTTLE Type 0: Not a Combination Product16/04/2001
3NDC:35356-926-9090 in 1 BOTTLE Type 0: Not a Combination Product16/04/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075786 04/16/2001

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