Last Updated: September 28, 2026

Details for New Drug Application (NDA): 219253

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NDA 219253 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, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Teva Pharms, Zydus Lifesciences, Hq Spclt Pharma, and Exela Pharma, and is included in fifty-eight NDAs. It is available from forty-eight 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-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for 219253

Tradename:	DILTIAZEM HYDROCHLORIDE
Applicant:	Zydus Lifesciences
Ingredient:	diltiazem hydrochloride
Patents:	0

Pharmacology for NDA: 219253

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

Suppliers and Packaging for NDA: 219253

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	219253	ANDA	Zydus Lifesciences Limited	70771-1929	70771-1929-1	100 TABLET in 1 BOTTLE (70771-1929-1)
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	219253	ANDA	Zydus Lifesciences Limited	70771-1929	70771-1929-5	500 TABLET in 1 BOTTLE (70771-1929-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Aug 8, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Aug 8, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Aug 8, 2025	TE:	AB	RLD:	No

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