MedPath
FDA Product

Famotidine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Famotidine

67046-172

Regulatory Information

67046-172

ANDA075511

C73584

December 19, 2018

USA

5728 5729

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

Contract Pharmacy Services-PA

945429777

Active Ingredients

FAMOTIDINE

Quantity: 20 mg in 1 1

Code: 5QZO15J2Z8

Class Code: ACTIB

Inactive Ingredients

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYETHYLENE GLYCOL 3000

Code: SA1B764746

Class Code: IACT

POLYETHYLENE GLYCOL 4000

Code: 4R4HFI6D95

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

Active Moieties

FAMOTIDINE

Code: 5QZO15J2Z8

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