| NDC Code | 60687-278-67 |
| Package Description | 5 TRAY in 1 CASE (60687-278-67) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-278-46) > 5 mL in 1 CUP, UNIT-DOSE (60687-278-40) |
| Product NDC | 60687-278 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
| Non-Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
| Dosage Form | SYRUP |
| Usage | ORAL |
| Start Marketing Date | 20210801 |
| Marketing Category Name | ANDA |
| Application Number | ANDA088008 |
| Manufacturer | American Health Packaging |
| Substance Name | HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE |
| Strength | 5; 1.5 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule | CII |