Last Updated: May 12, 2026

Details for New Drug Application (NDA): 215043

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NDA 215043 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma Ltd, Bionpharma, Carnegie, Contract Pharmacal, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Micro Labs, MSN, Navinta Llc, Novel Labs Inc, Novitium Pharma, Somerset Theraps Llc, Unichem, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Zydus Pharms, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Carlsbad, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, Mylan Pharms Inc, Natco Pharma, P And L, Perrigo R And D, Regcon Holdings, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Abbvie, and Baxter Hlthcare, and is included in ninety-two NDAs. It is available from one hundred and thirty-three suppliers. Additional details are available on the FAMOTIDINE profile page.

The generic ingredient in FAMOTIDINE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 215043

Tradename:	FAMOTIDINE
Applicant:	Novitium Pharma
Ingredient:	famotidine
Patents:	0

Pharmacology for NDA: 215043

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 215043

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 215043

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	215043	ANDA	Golden State Medical Supply, Inc.	51407-452	51407-452-50	50 mL in 1 BOTTLE (51407-452-50)
FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	215043	ANDA	ANI Pharmaceuticals, Inc.	70954-316	70954-316-10	50 mL in 1 BOTTLE (70954-316-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	40MG/5ML
Approval Date:	Apr 20, 2021	TE:	AB	RLD:	No

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