| NDC Code | 27808-086-02 |
|---|
| Package Description | 473 mL in 1 BOTTLE (27808-086-02) |
|---|
| Product NDC | 27808-086 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydrocodone Polistirex And Chlorpheniramine Polistirex |
|---|
| Proprietary Name Suffix | Extended-release |
|---|
| Non-Proprietary Name | Hydrocodone Polistirex And Chlorpheniramine Polistirex |
|---|
| Dosage Form | SUSPENSION, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20150306 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA091632 |
|---|
| Manufacturer | Tris Pharma Inc |
|---|
| Substance Name | CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE |
|---|
| Strength | 8; 10 |
|---|
| Strength Unit | mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|