NDC Code | 53746-617-10 |
Package Description | 1000 TABLET in 1 BOTTLE (53746-617-10) |
Product NDC | 53746-617 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
Non-Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20091217 |
Marketing Category Name | ANDA |
Application Number | ANDA090485 |
Manufacturer | Amneal Pharmaceuticals of New York LLC |
Substance Name | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
Strength | 325; 37.5 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
DEA Schedule | CIV |