NDC 71335-0483

Fexofenadine hydrochloride

Fexofenadine Hydrochloride

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

Product ID71335-0483_0d3ec8c9-4703-488b-98c9-1b0935275d78
NDC71335-0483
Product TypeHuman Otc Drug
Proprietary NameFexofenadine hydrochloride
Generic NameFexofenadine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA202039
Labeler NameBryant Ranch Prepack
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength180 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71335-0483-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-0483-1)
Marketing Start Date2017-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0483-5 [71335048305]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-25

NDC 71335-0483-4 [71335048304]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-25

NDC 71335-0483-3 [71335048303]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-25

NDC 71335-0483-6 [71335048306]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-25

NDC 71335-0483-2 [71335048302]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-25

NDC 71335-0483-1 [71335048301]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-25

NDC 71335-0483-7 [71335048307]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-25

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

OpenFDA Data

SPL SET ID:6a401b63-1d8d-46ec-933a-3d6bc8957170
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.