NDC Code | 68788-9968-5 |
Package Description | 50 TABLET, FILM COATED in 1 BOTTLE (68788-9968-5) |
Product NDC | 68788-9968 |
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 | 20151014 |
Marketing Category Name | ANDA |
Application Number | ANDA090460 |
Manufacturer | Preferred Pharmaceuticals 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 |