NDC Code | 57664-281-08 |
Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (57664-281-08) |
Product NDC | 57664-281 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
Non-Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20130528 |
Marketing Category Name | ANDA |
Application Number | ANDA091633 |
Manufacturer | Sun Pharmaceutical Industries, Inc. |
Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
Strength | 2.5; 200 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Opioid Agonist [EPC],Opioid Agonists [MoA] |
DEA Schedule | CII |