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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 215629

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NDA 215629 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Bionpharma, Saptalis Pharms, Vistapharm Llc, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Harman Finochem, Impax Labs, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Medicap Labs, Micro Labs, Mpp Pharma, Mylan Pharms Inc, Nostrum Pharms Llc, Novast Labs, Pharmobedient, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Regcon Holdings, Rk Pharma, Sandoz, Sciegen Pharms, Sun Pharm, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Utopic Pharms, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Aarxion Anda Hlding, Alkem, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Mylan, Provident Pharm, Senores Pharms, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, and Zydus Pharms Usa, and is included in one hundred and four NDAs. It is available from eighty suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for 215629

Tradename:	METFORMIN HYDROCHLORIDE
Applicant:	Rk Pharma
Ingredient:	metformin hydrochloride
Patents:	0

Pharmacology for NDA: 215629

Medical Subject Heading (MeSH) Categories for 215629

Hypoglycemic Agents

Suppliers and Packaging for NDA: 215629

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	215629	ANDA	VGYAAN Pharmaceuticals LLC	72664-227	72664-227-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72664-227-01)
METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	215629	ANDA	VGYAAN Pharmaceuticals LLC	72664-228	72664-228-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72664-228-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Jun 20, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	Jun 20, 2023	TE:		RLD:	No

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