| NDC Code | 0591-3630-10 |
| Package Description | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3630-10) |
| Product NDC | 0591-3630 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Hydromorphone Hydrochloride |
| Non-Proprietary Name | Hydromorphone Hydrochloride |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20140521 |
| Marketing Category Name | ANDA |
| Application Number | ANDA202144 |
| Manufacturer | Actavis Pharma, Inc. |
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
| Strength | 16 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |