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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 072781

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NDA 072781 describes NIFEDIPINE, which is a drug marketed by Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Teva, Velzen Pharma Pvt, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Martec Usa Llc, Novast Labs, Osmotica Pharm Us, Ph Health, Pharmobedient, Rising, Spil, Swiss Pharm, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in thirty NDAs. It is available from thirty-two suppliers. Additional details are available on the NIFEDIPINE profile page.

The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for 072781

Tradename:	NIFEDIPINE
Applicant:	Acella
Ingredient:	nifedipine
Patents:	0

Pharmacology for NDA: 072781

Mechanism of Action	Calcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 072781

Calcium Channel Blockers
Tocolytic Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 072781

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIFEDIPINE	nifedipine	CAPSULE;ORAL	072781	ANDA	NuCare Pharmaceuticals,Inc.	66267-831	66267-831-04	4 CAPSULE in 1 BOTTLE (66267-831-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jul 30, 1993	TE:	AB	RLD:	No

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