NDC 0904-6214

fexofenadine hydrochloride

Fexofenadine Hydrochloride

fexofenadine hydrochloride is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Fexofenadine Hydrochloride.

Product ID0904-6214_cdefa19e-7eed-469d-b640-9d7909a87acb
NDC0904-6214
Product TypeHuman Otc Drug
Proprietary Namefexofenadine hydrochloride
Generic NameFexofenadine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-04-14
Marketing CategoryANDA / ANDA
Application NumberANDA076447
Labeler NameMajor Pharmaceuticals
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength180 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0904-6214-18

1 BOTTLE in 1 CARTON (0904-6214-18) > 120 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2011-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6214-18 [00904621418]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-10-24
Marketing End Date2016-07-04

NDC 0904-6214-46 [00904621446]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-04-14
Marketing End Date2019-09-30

NDC 0904-6214-48 [00904621448]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-06-20
Marketing End Date2019-10-31

NDC 0904-6214-52 [00904621452]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-09-21
Marketing End Date2019-12-31

NDC 0904-6214-89 [00904621489]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-10-24
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

OpenFDA Data

SPL SET ID:c93a9479-02ba-4b5e-a013-9cc826dc3c3b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997420

    • NDC Crossover Matching brand name "fexofenadine hydrochloride" or generic name "Fexofenadine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0095Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-0097Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-0783Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-9898Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0378-0781Fexofenadine Hydrochloridefexofenadine
    0378-0782Fexofenadine Hydrochloridefexofenadine
    0615-5619Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-5620Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-7636Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-7696Fexofenadine HydrochlorideFexofenadine
    0904-5961Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5962Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5963Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-6214fexofenadine hydrochloridefexofenadine hydrochloride
    0904-6711Fexofenadine hydrochlorideFexofenadine hydrochloride
    0904-6979Fexofenadine HydrochlorideFexofenadine HCl
    0904-7050Fexofenadine HydrochlorideFexofenadine HCl
    10202-229Fexofenadine hydrochlorideFexofenadine hydrochloride
    10544-231Fexofenadine HydrochlorideFexofenadine HCl
    68071-2176fexofenadine hydrochloridefexofenadine hydrochloride
    68016-995Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68071-1896Fexofenadine hydrochlorideFexofenadine hydrochloride
    68071-3228Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68151-1452Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68151-3977fexofenadine hydrochloridefexofenadine hydrochloride
    68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE
    68196-976Fexofenadine hydrochlorideFexofenadine hydrochloride
    68554-5061Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68554-5063Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68554-5062Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68788-6848Fexofenadine hydrochlorideFexofenadine hydrochloride
    68788-6776fexofenadine hydrochloridefexofenadine hydrochloride
    69842-052Fexofenadine HydrochlorideFexofenadine Hydrochloride
    69848-002Fexofenadine HydrochlorideFexofenadine Hydrochloride
    70518-0746Fexofenadine HydrochlorideFexofenadine Hydrochloride
    70518-1218Fexofenadine hydrochlorideFexofenadine hydrochloride
    70518-1702fexofenadine hydrochloridefexofenadine hydrochloride
    70677-0008Fexofenadine hydrochlorideFexofenadine hydrochloride
    70677-0007Fexofenadine hydrochlorideFexofenadine hydrochloride
    71335-0290Fexofenadine HydrochlorideFexofenadine Hydrochloride
    71335-0721fexofenadine hydrochloridefexofenadine hydrochloride
    71335-0483Fexofenadine hydrochlorideFexofenadine hydrochloride
    71610-041fexofenadine hydrochloridefexofenadine hydrochloride
    13107-066Fexofenadine hydrochlorideFexofenadine hydrochloride
    13107-067Fexofenadine hydrochlorideFexofenadine hydrochloride
    21695-461Fexofenadine HydrochlorideFexofenadine Hydrochloride
    21695-462Fexofenadine HydrochlorideFexofenadine Hydrochloride
    30142-878Fexofenadine hydrochlorideFexofenadine hydrochloride
    33261-228fexofenadine hydrochloridefexofenadine hydrochloride
    35356-749fexofenadine hydrochloridefexofenadine hydrochloride
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