| NDC Code | 58716-433-16 |
|---|
| Package Description | 473 mL in 1 BOTTLE (58716-433-16) |
|---|
| Product NDC | 58716-433 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Obredon |
|---|
| Non-Proprietary Name | Hydrocodone Bitartrate And Guaifenesin |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20141230 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA205474 |
|---|
| Manufacturer | Sovereign Pharmaceuticals, LLC |
|---|
| Substance Name | GUAIFENESIN; HYDROCODONE BITARTRATE |
|---|
| Strength | 200; 2.5 |
|---|
| Strength Unit | mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Opioid Agonist [EPC], Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|