NDC Code | 0115-1315-03 |
Package Description | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-03) |
Product NDC | 0115-1315 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Oxymorphone Hydrochloride |
Non-Proprietary Name | Oxymorphone Hydrochloride |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20130102 |
Marketing Category Name | ANDA |
Application Number | ANDA079087 |
Manufacturer | Amneal Pharmaceuticals of New York LLC |
Substance Name | OXYMORPHONE HYDROCHLORIDE |
Strength | 7.5 |
Strength Unit | mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
DEA Schedule | CII |