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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 214361

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NDA 214361 describes VERAPAMIL HYDROCHLORIDE, which is a drug marketed by Mylan, Rising, Abraxis Pharm, 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, Actavis Elizabeth, Chartwell Rx, Mutual Pharm, Sun Pharm Industries, Warner Chilcott, and Watson Labs, and is included in sixty-five NDAs. It is available from forty-two 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-five suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for 214361

Tradename:	VERAPAMIL HYDROCHLORIDE
Applicant:	Gland
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 214361

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

Medical Subject Heading (MeSH) Categories for 214361

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 214361

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	INJECTABLE;INJECTION	214361	ANDA	Sagent Pharmaceuticals	25021-312	25021-312-02	25 VIAL in 1 CARTON (25021-312-02) / 2 mL in 1 VIAL
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	INJECTABLE;INJECTION	214361	ANDA	Sagent Pharmaceuticals	25021-312	25021-312-04	5 VIAL in 1 CARTON (25021-312-04) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2.5MG/ML
Approval Date:	Oct 15, 2020	TE:	AP	RLD:	No

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