Reprexain - 63717-902-99 - (hydrocodone bitartrate, ibuprofen)

Alphabetical Index


Drug Information of Reprexain

Product NDC: 63717-902
Proprietary Name: Reprexain
Non Proprietary Name: hydrocodone bitartrate, ibuprofen
Active Ingredient(s): 10; 200    mg/1; mg/1 & nbsp;   hydrocodone bitartrate, ibuprofen
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Reprexain

Product NDC: 63717-902
Labeler Name: Hawthorn Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076642
Marketing Category: ANDA
Start Marketing Date: 20081216

Package Information of Reprexain

Package NDC: 63717-902-99
Package Description: 1 TABLET, FILM COATED in 1 PACKET (63717-902-99)

NDC Information of Reprexain

NDC Code 63717-902-99
Proprietary Name Reprexain
Package Description 1 TABLET, FILM COATED in 1 PACKET (63717-902-99)
Product NDC 63717-902
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name hydrocodone bitartrate, ibuprofen
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20081216
Marketing Category Name ANDA
Labeler Name Hawthorn Pharmaceuticals, Inc.
Substance Name HYDROCODONE BITARTRATE; IBUPROFEN
Strength Number 10; 200
Strength Unit mg/1; mg/1
Pharmaceutical Classes Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

Complete Information of Reprexain


General Information