NDC 36800-319

topcare allergy relief

Fexofenadine Hydrochloride

topcare allergy relief is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Fexofenadine Hydrochloride.

Product ID36800-319_8bfb2194-057e-4ea5-96a6-6e1e38f40613
NDC36800-319
Product TypeHuman Otc Drug
Proprietary Nametopcare allergy relief
Generic NameFexofenadine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-01-23
Marketing CategoryANDA / ANDA
Application NumberANDA076447
Labeler NameTopco Associates LLC
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength180 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-319-13

5 BLISTER PACK in 1 CARTON (36800-319-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2020-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-319-22 [36800031922]

topcare allergy relief TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-09

NDC 36800-319-75 [36800031975]

topcare allergy relief TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-05-15

NDC 36800-319-39 [36800031939]

topcare allergy relief TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-23

NDC 36800-319-13 [36800031913]

topcare allergy relief TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-05-15

NDC 36800-319-95 [36800031995]

topcare allergy relief TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-05-15

NDC 36800-319-49 [36800031949]

topcare allergy relief TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076447
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-05-15

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

OpenFDA Data

SPL SET ID:59838f55-6ca0-4a87-b191-e91c20f8a679
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997420

    • NDC Crossover Matching brand name "topcare allergy relief" or generic name "Fexofenadine Hydrochloride"

    NDCBrand NameGeneric Name
    36800-319topcare allergy relieftopcare allergy relief
    36800-107topcare allergy relieftopcare allergy relief
    36800-954topcare allergy relieftopcare allergy relief
    36800-853Topcare Allergy ReliefTopcare Allergy Relief
    36800-755topcare allergy relieftopcare allergy relief
    10202-107AllergyFexofenadine hydrochloride
    11822-0425allergy relieffexofenadine hydrochloride
    11822-0571allergy relieffexofenadine hydrochloride
    11822-3698Allergy ReliefFexofenadine hydrochloride
    21130-784Allergy ReliefFexofenadine hydrochloride
    0363-0095Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-0097Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-0783Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-9898Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-5619Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-5620Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-7636Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5961Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5962Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5963Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-6214fexofenadine hydrochloridefexofenadine hydrochloride
    0904-6711Fexofenadine hydrochlorideFexofenadine hydrochloride
    10202-229Fexofenadine hydrochlorideFexofenadine hydrochloride
    13107-066Fexofenadine hydrochlorideFexofenadine hydrochloride
    13107-067Fexofenadine hydrochlorideFexofenadine hydrochloride
    21695-461Fexofenadine HydrochlorideFexofenadine Hydrochloride
    21695-462Fexofenadine HydrochlorideFexofenadine Hydrochloride
    30142-878Fexofenadine hydrochlorideFexofenadine hydrochloride
    0179-8325Fexofenadine Hydrochloride 180Fexofenadine Hydrochloride
    0113-0571good sense aller easefexofenadine hydrochloride
    0113-0847good sense aller easefexofenadine hydrochloride
    11673-571up and up allergy relieffexofenadine hydrochloride
    11673-617up and up allergy relieffexofenadine hydrochloride
    11673-800up and up allergy reliefFexofenadine Hydrochloride
    0363-0571wal fex allergyfexofenadine hydrochloride
    0363-0784Wal-FexFexofenadine hydrochloride
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