Last Updated: November 13, 2026

Details for New Drug Application (NDA): 219073

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NDA 219073 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alembic, Apotex, Biovail, Chartwell Rx, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Macleods Pharms, Mylan, Nesher Pharms, Novast Labs, Ph Health, Pharmobedient, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Amta, Sciegen Pharms, Adaptis, Apothecon, Chartwell Molecules, Ivax Sub Teva Pharms, Teva Pharms, Yichang Humanwell, Zydus Lifesciences, Hq Spclt Pharma, and Exela Pharma, and is included in fifty-nine NDAs. It is available from forty-nine suppliers. Additional details are available on the DILTIAZEM HYDROCHLORIDE profile page.

The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There is one drug master file entry for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for 219073

Tradename:	DILTIAZEM HYDROCHLORIDE
Applicant:	Utopic Pharms
Ingredient:	diltiazem hydrochloride
Patents:	0

Pharmacology for NDA: 219073

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

Suppliers and Packaging for NDA: 219073

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	219073	ANDA	Cranbury Pharmaceuticals, LLC	27808-322	27808-322-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27808-322-01)
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	219073	ANDA	Cranbury Pharmaceuticals, LLC	27808-323	27808-323-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27808-323-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Mar 24, 2025	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	90MG
Approval Date:	Mar 24, 2025	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Mar 24, 2025	TE:	AB1	RLD:	No

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