ZYDONE - HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Navigation: NDC > Supplier starting with: S > STAT RX USA LLC| Field | Value |
|---|---|
| NDC Code: | 16590-350 |
| Proprietary Name: | ZYDONE |
| Suffix: | |
| Non-Proprietary Name: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Dosage Form: | TABLET |
| Method: | ORAL |
| Original Marketing Date: | 01-12-1998 |
| Category Name: | ANDA |
| Application Number: | ANDA040288 |
| Labeler: | STAT RX USA LLC |
| Substance Name: | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Active Numerator Strength: | 400; 7.5 |
| Active Ingredient Unit: | mg/1; mg/1 |
| Pharm Classes: | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule: | CIII |