NDC 0642-7464

Benznidazole

Benznidazole

Benznidazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Exeltis Usa, Inc.. The primary component is Benznidazole.

Product ID0642-7464_5c01f59b-33b0-4e99-979f-78e4e242fbe2
NDC0642-7464
Product TypeHuman Prescription Drug
Proprietary NameBenznidazole
Generic NameBenznidazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-03-30
Marketing CategoryNDA / NDA
Application NumberNDA209570
Labeler NameExeltis USA, Inc.
Substance NameBENZNIDAZOLE
Active Ingredient Strength100 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0642-7464-10

1 BOTTLE in 1 CARTON (0642-7464-10) > 100 TABLET in 1 BOTTLE
Marketing Start Date2018-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0642-7464-10 [00642746410]

Benznidazole TABLET
Marketing CategoryNDA
Application NumberNDA209570
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-30

Drug Details

Active Ingredients

IngredientStrength
BENZNIDAZOLE100 mg/1

OpenFDA Data

SPL SET ID:8983d6a0-f63f-4f8e-bba4-38223f39e29b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1993222
  • 430551
  • UPC Code
  • 0306427464105
  • 0306427463122
  • NDC Crossover Matching brand name "Benznidazole" or generic name "Benznidazole"

    NDCBrand NameGeneric Name
    0642-7463Benznidazolebenznidazole
    0642-7464Benznidazolebenznidazole

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