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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 211610

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NDA 211610 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Teva, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Pharmobedient, Strides Pharma, Able, Am Therap, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Hibrow Hlthcare, Kv Pharm, Lederle, Mikart, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, and Whiteworth Town Plsn, and is included in eighty-nine NDAs. It is available from twenty-nine suppliers. Additional details are available on the ACETAMINOPHEN AND CODEINE PHOSPHATE profile page.

The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 211610

Tradename:	ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:	Hibrow Hlthcare
Ingredient:	acetaminophen; codeine phosphate
Patents:	0

Pharmacology for NDA: 211610

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 211610

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	211610	ANDA	Northwind Pharmaceuticals, LLC	51655-910	51655-910-54	15 TABLET in 1 BOTTLE, PLASTIC (51655-910-54)
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	211610	ANDA	Bryant Ranch Prepack	63629-1190	63629-1190-1	500 TABLET in 1 BOTTLE (63629-1190-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;15MG
Approval Date:	Jun 27, 2019	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;30MG
Approval Date:	Jun 27, 2019	TE:	AA	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;60MG
Approval Date:	Jun 27, 2019	TE:	AA	RLD:	No

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