EXALGO - HYDROMORPHONE HYDROCHLORIDE
Navigation: NDC > Supplier starting with: S > STAT RX USA LLC| Field | Value |
|---|---|
| NDC Code: | 16590-942 |
| Proprietary Name: | EXALGO |
| Suffix: | |
| Non-Proprietary Name: | HYDROMORPHONE HYDROCHLORIDE |
| Dosage Form: | TABLET, EXTENDED RELEASE |
| Method: | ORAL |
| Original Marketing Date: | 14-03-2011 |
| Category Name: | NDA |
| Application Number: | NDA021217 |
| Labeler: | STAT RX USA LLC |
| Substance Name: | HYDROMORPHONE HYDROCHLORIDE |
| Active Numerator Strength: | 8 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule: | CII |