NDC Code | 27808-086-03 |
Package Description | 1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-03) > 70 mL in 1 BOTTLE, UNIT-DOSE |
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 |