Last Updated: June 25, 2026

Details for New Drug Application (NDA): 089828

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NDA 089828 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-five 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-five suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 089828

Tradename:	ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:	Strides Pharma Intl
Ingredient:	acetaminophen; codeine phosphate
Patents:	0

Pharmacology for NDA: 089828

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 089828

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089828	ANDA	Strides Pharma Science Limited	64380-447	64380-447-01	100 TABLET in 1 BOTTLE (64380-447-01)
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089828	ANDA	Strides Pharma Science Limited	64380-447	64380-447-02	500 TABLET in 1 BOTTLE (64380-447-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;60MG
Approval Date:	Sep 30, 1988	TE:	AA	RLD:	No

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