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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 087508

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NDA 087508 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-four 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-four suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 087508

Tradename:	ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:	Genus Lifesciences
Ingredient:	acetaminophen; codeine phosphate
Patents:	0

Pharmacology for NDA: 087508

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 087508

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1008	0121-1008-12	12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	087508	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1008	0121-1008-40	40 TRAY in 1 CASE (0121-1008-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	120MG/5ML;12MG/5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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