Famotidine

Product NDC: 67296-2186
11-digit product format: 672962186
Labeler code: 67296
Product ID: 67296-2186_44f3f815-5d8e-4bc6-e063-6394a90aa4d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA217400
Marketing category: ANDA
Marketing start: 2024-08-06
Substance: FAMOTIDINE
Active strength: 20 mg/1
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 67296-2186_44f3f815-5d8e-4bc6-e063-6394a90aa4d7
SPL ID: 44f3f815-5d8e-4bc6-e063-6394a90aa4d7
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Famotidine
Generic name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2024-08-06
Marketing category: ANDA
Application number: ANDA217400
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA]; Histamine-2 Receptor Antagonist [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
FAMOTIDINE	20 mg/1

Package NDC	Description	Marketing start	Sample
67296-2186-3	30 TABLET, FILM COATED in 1 BOTTLE (67296-2186-3)	2024-09-18	No

UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67296-2186-3	67296218603	30 TABLET, FILM COATED in 1 BOTTLE (67296-2186-3)	2024-09-18	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Famotidine	Redpharm Drug	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	1