NDC 47335-724

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 Otc Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride.

Product ID47335-724_f57d619f-442a-407c-8cd6-a939a32d57c0
NDC47335-724
Product TypeHuman Otc Drug
Proprietary NameFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Generic NameFexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA090818
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47335-724-64

6 BLISTER PACK in 1 CARTON (47335-724-64) > 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-724-95 [47335072495]

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090818
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 47335-724-66 [47335072466]

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090818
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 47335-724-94 [47335072494]

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090818
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 47335-724-64 [47335072464]

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090818
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 47335-724-99 [47335072499]

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090818
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 47335-724-75 [47335072475]

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090818
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 47335-724-83 [47335072483]

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090818
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:8afc0167-17bf-4ccd-91c9-8fb9c4e241c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997406
    • UPC Code
  • 0347335724837

    • 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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