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] |