ULTRACET - 55289-617-20 - (tramadol hydrochloride and acetaminophen)

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Drug Information of ULTRACET

Product NDC: 55289-617
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: 55289-617
Labeler Name: PD-Rx Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021123
Marketing Category: NDA
Start Marketing Date: 20010815

Package Information of ULTRACET

Package NDC: 55289-617-20
Package Description: 20 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-617-20)

NDC Information of ULTRACET

NDC Code 55289-617-20
Proprietary Name ULTRACET
Package Description 20 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-617-20)
Product NDC 55289-617
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 PD-Rx 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