| NDC Code | 42192-612-16 |
|---|
| Package Description | 480 mL in 1 BOTTLE (42192-612-16) |
|---|
| Product NDC | 42192-612 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydrocodone Bitartrate And Chlorpheniramine Maleate |
|---|
| Non-Proprietary Name | Hydrocodone Bitartrate And Chlorpheniramine Maleate |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20170614 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA206891 |
|---|
| Manufacturer | Acella Pharmaceuticals, LLC |
|---|
| Substance Name | HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE |
|---|
| Strength | 5; 4 |
|---|
| Strength Unit | mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] |
|---|
| DEA Schedule | CII |
|---|