Ibuprofen - 42549-518-00 - (Ibuprofen)

Alphabetical Index


Drug Information of Ibuprofen

Product NDC: 42549-518
Proprietary Name: Ibuprofen
Non Proprietary Name: Ibuprofen
Active Ingredient(s): 800    mg/1 & nbsp;   Ibuprofen
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Ibuprofen

Product NDC: 42549-518
Labeler Name: STAT Rx USA LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078558
Marketing Category: ANDA
Start Marketing Date: 20091123

Package Information of Ibuprofen

Package NDC: 42549-518-00
Package Description: 100 TABLET, FILM COATED in 1 BOTTLE (42549-518-00)

NDC Information of Ibuprofen

NDC Code 42549-518-00
Proprietary Name Ibuprofen
Package Description 100 TABLET, FILM COATED in 1 BOTTLE (42549-518-00)
Product NDC 42549-518
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Ibuprofen
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20091123
Marketing Category Name ANDA
Labeler Name STAT Rx USA LLC
Substance Name IBUPROFEN
Strength Number 800
Strength Unit mg/1
Pharmaceutical Classes Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

Complete Information of Ibuprofen


General Information