NDC Code(s) : 43063-086-06
Packager : PD-Rx Pharmaceuticals, Inc.

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:43063-086(NDC:0172-5728)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color brown (beige) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code TEVA;5728
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-086-066 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075511 04/16/2001

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-086)

PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP 20mg Label Text

Famotidine

Tablets USP

20 mg

Rx only

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