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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021591

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NDA 021591 describes RIOMET, which is a drug marketed by Ranbaxy and Sun Pharm and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the RIOMET profile page.

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

Summary for 021591

Tradename:	RIOMET
Applicant:	Ranbaxy
Ingredient:	metformin hydrochloride
Patents:	0

Pharmacology for NDA: 021591

Medical Subject Heading (MeSH) Categories for 021591

Hypoglycemic Agents

Suppliers and Packaging for NDA: 021591

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591	NDA	Sun Pharmaceutical Industries, Inc.	10631-206	10631-206-01	118 mL in 1 BOTTLE (10631-206-01)
RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591	NDA	Sun Pharmaceutical Industries, Inc.	10631-206	10631-206-02	473 mL in 1 BOTTLE (10631-206-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 11, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021591

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591-001	Sep 11, 2003	6,890,957	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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