NDC 21695-820

FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride.

Product ID21695-820_e4020ca3-82d0-4668-b4bc-92e4a53c1f4e
NDC21695-820
Product TypeHuman Prescription Drug
Proprietary NameFEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE
Generic NameFexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-11-02
Marketing CategoryNDA / NDA
Application NumberNDA020786
Labeler NameRebel Distributors Corp
Substance NameFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1; mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-820-14

14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-820-14)
Marketing Start Date2009-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-820-14 [21695082014]

FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-02
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:e4020ca3-82d0-4668-b4bc-92e4a53c1f4e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997406

    • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]
    • Adrenergic alpha-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE" or generic name "Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0044Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    0363-0094Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    0363-2110Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    11822-0021Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    21695-820FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE
    30142-059Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    30142-097Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    37808-999Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    41415-995Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloridefexofenadine hydrochloride and pseudoephedrine hydrochloride
    46122-452Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    46122-694Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    47335-724Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    51316-007Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    51316-015Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    51660-037Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    56062-999Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    58602-807Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    62011-0376Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    69842-973Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
    69842-990Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    79903-108Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    21695-931Allegra D 12 Hour Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochloride
    41167-4310Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochloride
    41167-4320Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochloride
    50090-1203Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochloride
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