| NDC Code | 0121-4811-40 |
| Package Description | 4 TRAY in 1 CASE (0121-4811-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4811-05) |
| Product NDC | 0121-4811 |
| 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 | 20091228 |
| Marketing Category Name | ANDA |
| Application Number | ANDA088008 |
| Manufacturer | Pharmaceutical Associates, Inc. |
| Substance Name | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
| Strength | 1.5; 5 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | CII |