| NDC Code | 45802-107-52 |
| Package Description | 10 BLISTER PACK in 1 CARTON (45802-107-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 45802-107 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Pseudoephedrine Hydrochloride |
| Non-Proprietary Name | Pseudoephedrine Hcl |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20140524 |
| Marketing Category Name | ANDA |
| Application Number | ANDA075153 |
| Manufacturer | Padagis Israel Pharmaceuticals Ltd |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength | 120 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |