| NDC Code | 45802-230-68 |
| Package Description | 18 BLISTER PACK in 1 CARTON (45802-230-68) > 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 45802-230 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Guaifenesin And Pseudoephedrine Hydrochloride Extended Release |
| Non-Proprietary Name | Guaifenesin, Pseudoephedrine Hydrochloride |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20160129 |
| End Marketing Date | 20220228 |
| Marketing Category Name | ANDA |
| Application Number | ANDA091071 |
| Manufacturer | Padagis Israel Pharmaceuticals Ltd |
| Substance Name | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength | 600; 60 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |