Last Updated: November 8, 2026

Details for New Drug Application (NDA): 216471

« Back to Dashboard

NDA 216471 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 216471

Tradename:	VERAPAMIL HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 216471

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

Medical Subject Heading (MeSH) Categories for 216471

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 216471

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	INJECTABLE;INJECTION	216471	ANDA	FRESENIUS KABI USA, LLC	65219-384	65219-384-02	25 VIAL, SINGLE-DOSE in 1 CARTON (65219-384-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-384-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2.5MG/ML
Approval Date:	Apr 23, 2024	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.