| NDC Code | 51862-535-04 |
|---|
| Package Description | 118 mL in 1 BOTTLE, PLASTIC (51862-535-04) |
|---|
| Product NDC | 51862-535 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide |
|---|
| Non-Proprietary Name | Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide |
|---|
| Dosage Form | SYRUP |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190206 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA207676 |
|---|
| Manufacturer | Mayne Pharma |
|---|
| Substance Name | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 2; 10; 30 |
|---|
| Strength Unit | mg/5mL; mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC] |
|---|