NDC 0615-7695

Fexofenodine Hydrochloride

Fexofenadine

Fexofenodine Hydrochloride is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Fexofenadine Hydrochloride.

Product ID0615-7695_cb572295-e78c-40b8-8a9b-d5d1b36e7b07
NDC0615-7695
Product TypeHuman Otc Drug
Proprietary NameFexofenodine Hydrochloride
Generic NameFexofenadine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-08-08
Marketing CategoryANDA / ANDA
Application NumberANDA076447
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-7695-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7695-39)
Marketing Start Date2011-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7695-39 [00615769539]

Fexofenodine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-08
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:bbb5dbaa-dc63-4822-82cd-1acf9745f6f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997501
  • NDC Crossover Matching brand name "Fexofenodine Hydrochloride" or generic name "Fexofenadine"

    NDCBrand NameGeneric Name
    0615-7695Fexofenodine HydrochlorideFexofenadine
    55648-744FexofenadineFexofenadine
    55648-982FexofenadineFexofenadine
    55648-987FexofenadineFexofenadine
    64679-744FexofenadineFexofenadine
    64679-982FexofenadineFexofenadine
    64679-987FexofenadineFexofenadine
    72189-305FexofenadineFexofenadine
    0378-0781Fexofenadine Hydrochloridefexofenadine
    0378-0782Fexofenadine Hydrochloridefexofenadine
    0615-7696Fexofenadine HydrochlorideFexofenadine
    43353-760Fexofenadine Hydrochloridefexofenadine
    70518-0746Fexofenadine Hydrochloridefexofenadine

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