| NDC Code | 45802-147-62 |
| Package Description | 24 BLISTER PACK in 1 CARTON (45802-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 45802-147 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride |
| Non-Proprietary Name | Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20200331 |
| Marketing Category Name | ANDA |
| Application Number | ANDA210719 |
| Manufacturer | Padagis Israel Pharmaceuticals Ltd |
| 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] |