NDC Code | 55289-617-20 |
Package Description | 20 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-617-20) |
Product NDC | 55289-617 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Ultracet |
Non-Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
Dosage Form | TABLET, COATED |
Usage | ORAL |
Start Marketing Date | 20010815 |
Marketing Category Name | NDA |
Application Number | NDA021123 |
Manufacturer | PD-Rx Pharmaceuticals, Inc. |
Substance Name | TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN |
Strength | 37.5; 325 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule | CIV |