| NDC Code | 0703-0113-03 |
| Package Description | 10 VIAL in 1 CARTON (0703-0113-03) / 5 mL in 1 VIAL (0703-0113-01) |
| Product NDC | 0703-0113 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Hydromorphone Hydrochloride |
| Non-Proprietary Name | Hydromorphone Hydrochloride |
| Dosage Form | INJECTION, SOLUTION |
| Usage | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
| Start Marketing Date | 20110118 |
| Marketing Category Name | ANDA |
| Application Number | ANDA078591 |
| Manufacturer | Teva Parenteral Medicines, Inc. |
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
| Strength | 10 |
| Strength Unit | mg/mL |
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |