NDC 68554-5063

Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

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

Product ID68554-5063_12c87ec8-6af5-41bf-931a-8937e63cbad4
NDC68554-5063
Product TypeHuman Otc Drug
Proprietary NameFexofenadine Hydrochloride
Generic NameFexofenadine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-08-23
Marketing CategoryANDA / ANDA
Application NumberANDA204097
Labeler NameHetero Labs Limited
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength180 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68554-5063-1

1 BOTTLE in 1 CARTON (68554-5063-1) > 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2016-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68554-5063-2 [68554506302]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204097
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23
Inactivation Date2020-01-31

NDC 68554-5063-3 [68554506303]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204097
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23

NDC 68554-5063-5 [68554506305]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204097
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23
Inactivation Date2020-01-31

NDC 68554-5063-1 [68554506301]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204097
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23
Inactivation Date2020-01-31

NDC 68554-5063-4 [68554506304]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204097
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23

NDC 68554-5063-6 [68554506306]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204097
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23
Inactivation Date2020-01-31

NDC 68554-5063-0 [68554506300]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204097
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

OpenFDA Data

SPL SET ID:412af925-12e9-405f-b3c3-d5c3d0b5d5c2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997488
  • 997420
  • 997501

    • 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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