| NDC Code | 43602-268-05 |
|---|
| Package Description | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-268-05) |
|---|
| Product NDC | 43602-268 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydromorphone Hydrochloride |
|---|
| Non-Proprietary Name | Hydromorphone Hydrochloride |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20200924 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA212133 |
|---|
| Manufacturer | Ascent Pharmaceuticals, Inc. |
|---|
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
|---|
| Strength | 16 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|