NDC Code | 13107-004-05 |
Package Description | 500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05) |
Product NDC | 13107-004 |
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 | 20160602 |
Marketing Category Name | ANDA |
Application Number | ANDA204575 |
Manufacturer | Aurolife Pharma, LLC |
Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
Strength | 7.5; 200 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA] |
DEA Schedule | CII |