NDC Code | 0555-0778-02 |
Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (0555-0778-02) |
Product NDC | 0555-0778 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Oxycodone Hydrochloride And Ibuprofen |
Non-Proprietary Name | Oxycodone Hydrochloride And Ibuprofen |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20071204 |
Marketing Category Name | ANDA |
Application Number | ANDA078316 |
Manufacturer | Barr Laboratories Inc. |
Substance Name | IBUPROFEN; OXYCODONE HYDROCHLORIDE |
Strength | 400; 5 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule | CII |