REZIRA - hydrocodone bitartrate, pseudoephedrine hydrochloride
Navigation: NDC > Supplier starting with: H > HAWTHORN PHARMACEUTICALS, INC.| Field | Value |
|---|---|
| NDC Code: | 63717-875 |
| Proprietary Name: | REZIRA |
| Suffix: | |
| Non-Proprietary Name: | hydrocodone bitartrate, pseudoephedrine hydrochloride |
| Dosage Form: | SOLUTION |
| Method: | ORAL |
| Original Marketing Date: | 08-06-2011 |
| Category Name: | NDA |
| Application Number: | NDA022442 |
| Labeler: | HAWTHORN PHARMACEUTICALS, INC. |
| Substance Name: | HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Active Numerator Strength: | 5; 60 |
| Active Ingredient Unit: | mg/5mL; mg/5mL |
| Pharm Classes: | Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] |
| DEA Schedule: | CIII |