NDC Code: |
16590-296 |
Proprietary Name: |
Hydrocodone Bitartrate and Ibuprofen |
Suffix: |
|
Non-Proprietary Name: |
hydrocodone bitartrate and ibuprofen |
Dosage Form: |
TABLET, FILM COATED |
Method: |
ORAL |
Original Marketing Date: |
06-11-2006 |
Category Name: |
ANDA |
Application Number: |
ANDA077723 |
Labeler: |
STAT RX USA LLC |
Substance Name: |
HYDROCODONE BITARTRATE; IBUPROFEN |
Active Numerator Strength: |
7.5; 200 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule: |
CIII |