NDC Code | 57664-537-88 |
Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (57664-537-88) |
Product NDC | 57664-537 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
Non-Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20051216 |
Marketing Category Name | ANDA |
Application Number | ANDA077184 |
Manufacturer | Sun Pharmaceutical Industries, Inc. |
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 |