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 |