| NDC Code | 65162-038-06 |
|---|
| Package Description | 1 BOTTLE in 1 CARTON (65162-038-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE |
|---|
| Product NDC | 65162-038 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Guaifenesin And Dextromethorphan Hbr |
|---|
| Non-Proprietary Name | Guaifenesin And Dextromethorphan Hbr |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20181101 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA209692 |
|---|
| Manufacturer | Amneal Pharmaceuticals LLC |
|---|
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
|---|
| Strength | 30; 600 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
|---|