NDC Code | 65162-115-11 |
Package Description | 1000 TABLET in 1 BOTTLE (65162-115-11) |
Product NDC | 65162-115 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
Non-Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20160630 |
Marketing Category Name | ANDA |
Application Number | ANDA040746 |
Manufacturer | Amneal Pharmaceuticals LLC |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength | 325; 7.5 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
DEA Schedule | CII |