Last Updated: June 9, 2026

Details for New Drug Application (NDA): 040736

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NDA 040736 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-four 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-six suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for 040736

Tradename:	HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Applicant:	Amneal Pharms Ny
Ingredient:	acetaminophen; hydrocodone bitartrate
Patents:	0

Pharmacology for NDA: 040736

Mechanism of Action	Opioid Agonists

Suppliers and Packaging for NDA: 040736

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040736	ANDA	AvPAK	50268-401	50268-401-15	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-401-15) / 1 TABLET in 1 BLISTER PACK (50268-401-11)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040736	ANDA	AvPAK	50268-402	50268-402-15	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-402-15) / 1 TABLET in 1 BLISTER PACK (50268-402-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;5MG
Approval Date:	Aug 25, 2006	TE:	AA	RLD:	No

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