NDC 63187-334

fexofenadine hydrochloride

Fexofenadine Hydrochloride

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

Product ID63187-334_059cc475-9988-452d-9aa5-19a69292cce1
NDC63187-334
Product TypeHuman Otc Drug
Proprietary Namefexofenadine hydrochloride
Generic NameFexofenadine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-04-22
Marketing End Date2022-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA076447
Labeler NameProficient Rx LP
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength180 mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN

Packaging

NDC 63187-334-20

20 TABLET, FILM COATED in 1 BOTTLE (63187-334-20)
Marketing Start Date2018-11-01
Marketing End Date2022-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-334-30 [63187033430]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 63187-334-20 [63187033420]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 63187-334-60 [63187033460]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 63187-334-90 [63187033490]

fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

OpenFDA Data

SPL SET ID:dfb94a2a-4a83-4884-9720-b40bee790a20
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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