Last Updated: September 24, 2026

Details for New Drug Application (NDA): 040643

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NDA 040643 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 Pharms Nc, 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, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Rising, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Pharmobedient, Ani Pharms, Hetero Labs Ltd Iii, and Rubicon Research, and is included in ninety-two NDAs. It is available from forty-five 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 five 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 040643

Tradename:	PROMETHAZINE HYDROCHLORIDE
Applicant:	Pharm Assoc
Ingredient:	promethazine hydrochloride
Patents:	0

Pharmacology for NDA: 040643

Medical Subject Heading (MeSH) Categories for 040643

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Suppliers and Packaging for NDA: 040643

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SYRUP;ORAL	040643	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1854	0121-1854-16	473 mL in 1 BOTTLE (0121-1854-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	6.25MG/5ML
Approval Date:	Apr 26, 2006	TE:	AA	RLD:	No

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