| NDC Code | 68094-048-61 |
| Package Description | 10 BLISTER PACK in 1 CARTON (68094-048-61) / 10 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK (68094-048-59) |
| Product NDC | 68094-048 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Guaifenesin Extended-release |
| Non-Proprietary Name | Guaifenesin |
| Dosage Form | TABLET, MULTILAYER, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20230322 |
| Marketing Category Name | ANDA |
| Application Number | ANDA078912 |
| Manufacturer | Precision Dose Inc. |
| Substance Name | GUAIFENESIN |
| Strength | 600 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |