ULTRACET - 50458-650-10 - (tramadol hydrochloride and acetaminophen)

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Drug Information of ULTRACET

Product NDC: 50458-650
Proprietary Name: ULTRACET
Non Proprietary Name: tramadol hydrochloride and acetaminophen
Active Ingredient(s): 325; 37.5    mg/1; mg/1 & nbsp;   tramadol hydrochloride and acetaminophen
Administration Route(s): ORAL
Dosage Form(s): TABLET, COATED
Coding System: National Drug Codes(NDC)

Labeler Information of ULTRACET

Product NDC: 50458-650
Labeler Name: Janssen Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021123
Marketing Category: NDA
Start Marketing Date: 20010815

Package Information of ULTRACET

Package NDC: 50458-650-10
Package Description: 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-650-10) > 10 TABLET, COATED in 1 BLISTER PACK

NDC Information of ULTRACET

NDC Code 50458-650-10
Proprietary Name ULTRACET
Package Description 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-650-10) > 10 TABLET, COATED in 1 BLISTER PACK
Product NDC 50458-650
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name tramadol hydrochloride and acetaminophen
Dosage Form Name TABLET, COATED
Route Name ORAL
Start Marketing Date 20010815
Marketing Category Name NDA
Labeler Name Janssen Pharmaceuticals, Inc.
Substance Name ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Strength Number 325; 37.5
Strength Unit mg/1; mg/1
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of ULTRACET


General Information