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] |