NDC Code | 0591-3494-01 |
Package Description | 100 TABLET in 1 BOTTLE, PLASTIC (0591-3494-01) |
Product NDC | 0591-3494 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Oxycodone Hydrochloride And Ibuprofen |
Non-Proprietary Name | Oxycodone Hydrochloride And Ibuprofen |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20071201 |
Marketing Category Name | ANDA |
Application Number | ANDA078394 |
Manufacturer | Watson Laboratories, Inc. |
Substance Name | OXYCODONE HYDROCHLORIDE; IBUPROFEN |
Strength | 5; 400 |
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 |