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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 040881

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NDA 040881 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Abhai Llc, Able, Actavis Labs Fl Inc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Elite Labs Inc, Epic Pharma Llc, Granules, Halsey, Hibrow Hlthcare, Ivax Pharms, Lannett Co Inc, Mutual Pharm, Novel Labs Inc, Ph Health, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sanaluz, Sandoz, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Ucb Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, and Watson Labs Florida, and is included in one hundred and twenty-six NDAs. It is available from thirty-seven suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND ACETAMINOPHEN profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND ACETAMINOPHEN is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for 040881

Tradename:	HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Applicant:	Mikart
Ingredient:	acetaminophen; hydrocodone bitartrate
Patents:	0

Pharmacology for NDA: 040881

Mechanism of Action	Opioid Agonists

Suppliers and Packaging for NDA: 040881

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	SOLUTION;ORAL	040881	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0843	0054-0843-63	473 mL in 1 BOTTLE (0054-0843-63)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	300MG/15ML;10MG/15ML
Approval Date:	Feb 25, 2010	TE:		RLD:	No

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