NDC Code | 54868-6388-0 |
Package Description | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (54868-6388-0) |
Product NDC | 54868-6388 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Exalgo |
Non-Proprietary Name | Hydromorphone Hydrochloride |
Dosage Form | TABLET, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20121231 |
Marketing Category Name | NDA |
Application Number | NDA021217 |
Manufacturer | Physicians Total Care, Inc. |
Substance Name | HYDROMORPHONE HYDROCHLORIDE |
Strength | 16 |
Strength Unit | mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule | CII |