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Last Updated: April 4, 2025

Suppliers and packagers for generic ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

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CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start

Nostrum Labs Inc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	090180	ANDA	Nostrum Laboratories, Inc.	70408-185-31	118 mL in 1 BOTTLE (70408-185-31)	2010-03-17
Nostrum Labs Inc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	090180	ANDA	Nostrum Laboratories, Inc.	70408-185-34	473 mL in 1 BOTTLE (70408-185-34)	2010-03-17
Pharm Assoc	PROMETHAZINE WITH CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	040650	ANDA	Proficient Rx LP	63187-271-04	4 mL in 1 BOTTLE (63187-271-04)	2006-01-31
Quagen	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	214238	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-139-06	118 mL in 1 BOTTLE, PLASTIC (70752-139-06)	2020-10-08
Quagen	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	214238	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-139-12	473 mL in 1 BOTTLE, PLASTIC (70752-139-12)	2020-10-08
Tris Pharma Inc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386	ANDA	Tris Pharma Inc	27808-065-02	473 mL in 1 BOTTLE, PLASTIC (27808-065-02)	2018-03-12
Tris Pharma Inc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386	ANDA	Bryant Ranch Prepack	72162-2042-2	473 mL in 1 BOTTLE, PLASTIC (72162-2042-2)	2018-03-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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