| NDC Code | 0054-0843-63 |
| Package Description | 473 mL in 1 BOTTLE (0054-0843-63) |
| Product NDC | 0054-0843 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
| Non-Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
| Dosage Form | LIQUID |
| Usage | ORAL |
| Start Marketing Date | 20250602 |
| Marketing Category Name | ANDA |
| Application Number | ANDA040881 |
| Manufacturer | Hikma Pharmaceuticals USA Inc. |
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Strength | 300; 10 |
| Strength Unit | mg/15mL; mg/15mL |
| Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | CII |