| NDC Code | 70069-661-10 |
| Package Description | 1 VIAL, MULTI-DOSE in 1 CARTON (70069-661-10) / 10 mL in 1 VIAL, MULTI-DOSE |
| Product NDC | 70069-661 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Nalbuphine Hydrochloride |
| Non-Proprietary Name | Nalbuphine Hydrochloride |
| Dosage Form | INJECTION |
| Usage | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
| Start Marketing Date | 20240926 |
| Marketing Category Name | ANDA |
| Application Number | ANDA216049 |
| Manufacturer | Somerset Therapeutics, LLC |
| Substance Name | NALBUPHINE HYDROCHLORIDE |
| Strength | 10 |
| Strength Unit | mg/mL |
| Pharmacy Classes | Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA] |