benznidazole

Generic: benznidazole

Labeler: exeltis usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name benznidazole
Generic Name benznidazole
Labeler exeltis usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benznidazole 12.5 mg/1

Manufacturer
Exeltis USA, Inc.

Identifiers & Regulatory

Product NDC 0642-7463
Product ID 0642-7463_3eddc863-2c5b-6505-e063-6394a90a2423
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209570
Listing Expiration 2026-12-31
Marketing Start 2018-03-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06427463
Hyphenated Format 0642-7463

Supplemental Identifiers

RxCUI
430551 1993222
UNII
YC42NRJ1ZD

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name benznidazole (source: ndc)
Generic Name benznidazole (source: ndc)
Application Number NDA209570 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

0642-7463-12 1 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE

Ingredients (1)

benznidazole (12.5 mg/1)

Linked Drug Pages (1)

Benznidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3eddc863-2c5b-6505-e063-6394a90a2423", "openfda": {"unii": ["YC42NRJ1ZD"], "rxcui": ["430551", "1993222"], "spl_set_id": ["8983d6a0-f63f-4f8e-bba4-38223f39e29b"], "manufacturer_name": ["Exeltis USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0642-7463-12)  / 100 TABLET in 1 BOTTLE", "package_ndc": "0642-7463-12", "marketing_start_date": "20180330"}], "brand_name": "Benznidazole", "product_id": "0642-7463_3eddc863-2c5b-6505-e063-6394a90a2423", "dosage_form": "TABLET", "product_ndc": "0642-7463", "generic_name": "benznidazole", "labeler_name": "Exeltis USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benznidazole", "active_ingredients": [{"name": "BENZNIDAZOLE", "strength": "12.5 mg/1"}], "application_number": "NDA209570", "marketing_category": "NDA", "marketing_start_date": "20180330", "listing_expiration_date": "20261231"}