Last Updated: November 8, 2026

Details for New Drug Application (NDA): 070995

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NDA 070995 describes VERAPAMIL HYDROCHLORIDE, which is a drug marketed by Mylan, Rising, Abraxis Pharm, Aspiro, Bedford, Eugia Pharma, Fresenius Kabi Usa, Gland, Heritage, Hospira, Intl Medication, Knack, Luitpold, Mankind Pharma, Marsam Pharms Llc, Smith And Nephew, Solopak, Zydus Pharms, Amneal, Caplin, Exela Pharma, Micro Labs, Nephron, Somerset, Somerset Theraps Llc, Apotex Corp, Cadila Pharms Ltd, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Pliva, Strides Pharma Intl, Sun Pharm Inds Inc, Zydus Lifesciences, Actavis Elizabeth, Chartwell Rx, Mutual Pharm, Sun Pharm Industries, Warner Chilcott, and Watson Labs, and is included in sixty-eight NDAs. It is available from forty-four suppliers. Additional details are available on the VERAPAMIL HYDROCHLORIDE profile page.

The generic ingredient in VERAPAMIL HYDROCHLORIDE is verapamil hydrochloride. There is one drug master file entry for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for 070995

Tradename:	VERAPAMIL HYDROCHLORIDE
Applicant:	Watson Labs
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 070995

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 070995

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 070995

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	070995	ANDA	Actavis Pharma, Inc.	0591-0343	0591-0343-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-01)
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	070995	ANDA	Actavis Pharma, Inc.	0591-0343	0591-0343-05	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Oct 1, 1986	TE:	AB	RLD:	No

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