| NDC Code | 52959-413-60 |
|---|
| Package Description | 60 TABLET in 1 BOTTLE, PLASTIC (52959-413-60) |
|---|
| Product NDC | 52959-413 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydromorphone Hydrochloride |
|---|
| Non-Proprietary Name | Hydromorphone Hydrochloride |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20091209 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA077471 |
|---|
| Manufacturer | H.J. Harkins Company, Inc. |
|---|
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
|---|
| Strength | 8 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|