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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040596

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NDA 040596 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt Bio Ag, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Sun Pharma Canada, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Pharm Assoc, Quagen, Strides Pharma, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Pharmobedient, and Ani Pharms, and is included in ninety NDAs. It is available from forty-eight suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for 040596

Tradename:	PROMETHAZINE HYDROCHLORIDE
Applicant:	Zydus Pharms Usa
Ingredient:	promethazine hydrochloride
Patents:	0

Pharmacology for NDA: 040596

Medical Subject Heading (MeSH) Categories for 040596

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Suppliers and Packaging for NDA: 040596

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040596	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8154	0615-8154-39	30 TABLET in 1 BLISTER PACK (0615-8154-39)
PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040596	ANDA	A-S Medication Solutions	50090-4811	50090-4811-0	5 TABLET in 1 BOTTLE (50090-4811-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Nov 18, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 18, 2005	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 18, 2005	TE:	AB	RLD:	No

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