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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090664

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NDA 090664 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Anda Repository, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Navinta Llc, Pharmobedient, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Qilu Pharm Hainan, Rk Pharma, Sun Pharm, Inforlife, Caplin, and Cipla, and is included in twenty-six NDAs. It is available from twenty-two suppliers. Additional details are available on the NICARDIPINE HYDROCHLORIDE profile page.

The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for 090664

Tradename:	NICARDIPINE HYDROCHLORIDE
Applicant:	Rk Pharma
Ingredient:	nicardipine hydrochloride
Patents:	0

Pharmacology for NDA: 090664

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 090664

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 090664

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	090664	ANDA	Archis Pharma LLC	72819-149	72819-149-07	10 VIAL in 1 CARTON (72819-149-07) / 10 mL in 1 VIAL (72819-149-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/10ML (2.5MG/ML)
Approval Date:	Nov 17, 2009	TE:	AP	RLD:	No

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