| NDC Code | 0536-1431-34 |
|---|
| Package Description | 2 BLISTER PACK in 1 CARTON (0536-1431-34) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 0536-1431 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride |
|---|
| Non-Proprietary Name | Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20240517 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA209116 |
|---|
| Manufacturer | Rugby Laboratories |
|---|
| Substance Name | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 60; 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] |
|---|