NDC Code | 0121-4811-05 |
Package Description | 4 TRAY in 1 CASE (0121-4811-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE |
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 | 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 |