"0536-1431-07" National Drug Code (NDC)

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride 3 BLISTER PACK in 1 CARTON (0536-1431-07) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
(Rugby Laboratories)

NDC Code0536-1431-07
Package Description3 BLISTER PACK in 1 CARTON (0536-1431-07) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product NDC0536-1431
Product Type NameHUMAN OTC DRUG
Proprietary NameFexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
Non-Proprietary NameFexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20240517
Marketing Category NameANDA
Application NumberANDA209116
ManufacturerRugby Laboratories
Substance NameFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength60; 120
Strength Unitmg/1; mg/1
Pharmacy ClassesAdrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]

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