NDC Code | 72865-169-01 |
Package Description | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-169-01) |
Product NDC | 72865-169 |
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 | XLCare Pharmaceuticals, Inc. |
Substance Name | HYDROMORPHONE HYDROCHLORIDE |
Strength | 12 |
Strength Unit | mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
DEA Schedule | CII |