NDC Code | 43063-531-60 |
Package Description | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-531-60) |
Product NDC | 43063-531 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Xartemis |
Proprietary Name Suffix | Xr |
Non-Proprietary Name | Oxycodone Hydrochloride And Acetaminophen |
Dosage Form | TABLET, COATED |
Usage | ORAL |
Start Marketing Date | 20130430 |
End Marketing Date | 20190531 |
Marketing Category Name | NDA |
Application Number | NDA204031 |
Manufacturer | PD-Rx Pharmaceuticals, Inc. |
Substance Name | OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN |
Strength | 7.5; 325 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule | CII |