NDC Code(s) : 51655-102-30, 51655-102-26
Packager : Northwind 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:51655-102(NDC:0172-5729)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color brown (tan) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code TEVA;5729
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51655-102-3030 in 1 BOTTLE, DISPENSING Type 0: Not a Combination Product25/08/2014
2NDC:51655-102-2690 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075511 08/25/2014

LABELER - Northwind Pharmaceuticals(036986393)

REGISTRANT - Northwind Pharmaceuticals(036986393)

Establishment
Name Address ID/FEI Business Operations
Northwind Pharmaceuticals 036986393 repack(51655-102)

PRINCIPAL DISPLAY PANEL

NDC: 51655-102-30

Label