Last Updated: August 9, 2026

Details for New Drug Application (NDA): 219252

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NDA 219252 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, 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-seven 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 are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for 219252

Tradename:	VERAPAMIL HYDROCHLORIDE
Applicant:	Zydus Lifesciences
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 219252

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

Medical Subject Heading (MeSH) Categories for 219252

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 219252

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	219252	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-561	68382-561-01	100 TABLET in 1 BOTTLE (68382-561-01)
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	219252	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-561	68382-561-05	500 TABLET in 1 BOTTLE (68382-561-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Nov 24, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Nov 24, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	240MG
Approval Date:	Nov 24, 2025	TE:	AB	RLD:	No

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