NDC 53002-7940

Fexofenadine Hydrochloride

Fexofenadine Hcl

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

Product ID53002-7940_527af26b-41f6-4cce-b258-1d1a19a028aa
NDC53002-7940
Product TypeHuman Otc Drug
Proprietary NameFexofenadine Hydrochloride
Generic NameFexofenadine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-08-08
Marketing CategoryANDA / ANDA
Application NumberANDA076447
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53002-7940-1

10 TABLET, FILM COATED in 1 BOTTLE (53002-7940-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-7940-1 [53002794001]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-7940-2 [53002794002]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-7940-3 [53002794003]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:d72f535b-53b8-468e-886c-dbd3b3ce1e62
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997501

    • NDC Crossover Matching brand name "Fexofenadine Hydrochloride" or generic name "Fexofenadine Hcl"

    NDCBrand NameGeneric Name
    0363-0095Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-0097Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-0783Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-9898Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0378-0781Fexofenadine Hydrochloridefexofenadine
    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
    0615-5620Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-5619Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-7696Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-7636Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5962Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-6214fexofenadine hydrochloridefexofenadine hydrochloride
    0904-5961Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5963Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-6711Fexofenadine hydrochlorideFexofenadine hydrochloride
    10544-231Fexofenadine 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
    41250-784Fexofenadine HydrochlorideFexofenadine Hydrochloride
    42254-123Fexofenadine HydrochlorideFexofenadine Hydrochloride
    42291-297Fexofenadine hydrochlorideFexofenadine hydrochloride
    42254-166fexofenadine hydrochloridefexofenadine hydrochloride
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