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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 210534

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NDA 210534 describes CEFDINIR, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, Chartwell Rx, Lupin, and Teva Pharms, and is included in twelve NDAs. It is available from twenty-seven suppliers. Additional details are available on the CEFDINIR profile page.

The generic ingredient in CEFDINIR is cefdinir. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the cefdinir profile page.

Summary for 210534

Tradename:	CEFDINIR
Applicant:	Alkem Labs Ltd
Ingredient:	cefdinir
Patents:	0

Pharmacology for NDA: 210534

Suppliers and Packaging for NDA: 210534

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	210534	ANDA	A-S Medication Solutions	50090-5811	50090-5811-0	60 mL in 1 BOTTLE (50090-5811-0)
CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	210534	ANDA	Ascend Laboratories, LLC	67877-547	67877-547-88	100 mL in 1 BOTTLE (67877-547-88)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Feb 19, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	250MG/5ML
Approval Date:	Feb 19, 2021	TE:	AB	RLD:	No

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