| NDC Code | 63717-875-16 |
|---|
| Package Description | 480 mL in 1 BOTTLE (63717-875-16) |
|---|
| Product NDC | 63717-875 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Rezira |
|---|
| Non-Proprietary Name | Hydrocodone Bitartrate, Pseudoephedrine Hydrochloride |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20110608 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA022442 |
|---|
| Manufacturer | Hawthorn Pharmaceuticals, Inc. |
|---|
| Substance Name | HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 5; 60 |
|---|
| Strength Unit | mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|