NDC Code | 0536-1279-35 |
Package Description | 24 BLISTER PACK in 1 CARTON (0536-1279-35) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Product NDC | 0536-1279 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Rugby Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride |
Non-Proprietary Name | Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20200309 |
Marketing Category Name | ANDA |
Application Number | ANDA210719 |
Manufacturer | Rugby Laboratories |
Substance Name | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
Strength | 5; 120 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] |