| Product NDC: | 63481-624 |
| Proprietary Name: | OPANA |
| Non Proprietary Name: | Oxymorphone Hydrochloride |
| Active Ingredient(s): | 1 mg/mL & nbsp; Oxymorphone Hydrochloride |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63481-624 |
| Labeler Name: | Endo Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA011707 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19590601 |
| Package NDC: | 63481-624-10 |
| Package Description: | 10 AMPULE in 1 CARTON (63481-624-10) > 1 mL in 1 AMPULE (63481-624-01) |
| NDC Code | 63481-624-10 |
| Proprietary Name | OPANA |
| Package Description | 10 AMPULE in 1 CARTON (63481-624-10) > 1 mL in 1 AMPULE (63481-624-01) |
| Product NDC | 63481-624 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Oxymorphone Hydrochloride |
| Dosage Form Name | INJECTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
| Start Marketing Date | 19590601 |
| Marketing Category Name | NDA |
| Labeler Name | Endo Pharmaceuticals Inc. |
| Substance Name | OXYMORPHONE HYDROCHLORIDE |
| Strength Number | 1 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |