NDC 55648-982

Fexofenadine

Fexofenadine

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

Product ID55648-982_865eb588-6553-4222-b98e-3759fab38f2d
NDC55648-982
Product TypeHuman Otc Drug
Proprietary NameFexofenadine
Generic NameFexofenadine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-02-08
Marketing CategoryANDA / ANDA
Application NumberANDA079112
Labeler NameWockhardt Limited
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55648-982-09

2 BLISTER PACK in 1 CARTON (55648-982-09) > 6 TABLET, FILM COATED in 1 BLISTER PACK (55648-982-08)
Marketing Start Date2012-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-982-08 [55648098208]

Fexofenadine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079112
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-08

NDC 55648-982-09 [55648098209]

Fexofenadine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079112
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:db8d895c-1004-4d5b-bc0d-81f192bfc7b0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997488
  • 997420
  • 997501
    • UPC Code
  • 0364679987117
  • 0364679987124
  • 0364679987100
  • 0364679987131
  • 0364679987148
  • 0364679744093
  • 0364679982099

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

    NDCBrand NameGeneric Name
    55648-744FexofenadineFexofenadine
    55648-982FexofenadineFexofenadine
    55648-987FexofenadineFexofenadine
    64679-744FexofenadineFexofenadine
    64679-982FexofenadineFexofenadine
    64679-987FexofenadineFexofenadine
    72189-305FexofenadineFexofenadine
    0378-0781Fexofenadine Hydrochloridefexofenadine
    0378-0782Fexofenadine Hydrochloridefexofenadine
    0615-7696Fexofenadine HydrochlorideFexofenadine
    43353-760Fexofenadine Hydrochloridefexofenadine
    70518-0746Fexofenadine Hydrochloridefexofenadine
    0615-7695Fexofenodine HydrochlorideFexofenadine
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