FDA.reportPublic FDA data

Benznidazole

Product NDC
0642-7464
11-digit product format
006427464
Labeler code
0642
Product ID
0642-7464_3eddc863-2c5b-6505-e063-6394a90a2423
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benznidazole
Dosage form
TABLET
Route
ORAL
Labeler
Exeltis USA, Inc.
Application
NDA209570
Marketing category
NDA
Marketing start
2018-03-30
Substance
BENZNIDAZOLE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benznidazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZNIDAZOLE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYC42NRJ1ZD
Rxcui430551, 1993222

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0642-7464-102023-11-10C16284748780-1f386c649-b975-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017
0642-7464-102023-07-28C16284748780-1f386c649-b975-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017
0642-7464-102023-02-12C16284748780-1f386c649-b975-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017
0642-7464-102023-01-30C16284748780-1f386c649-b975-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0642-7464-10Benznidazole100 in 1 BOTTLETABLET10013
0642-7464-10Benznidazole1 in 1 CARTONTABLET113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0642-7464-10EA - Each0642-74646447aa7c-b4b4-4da9-acd5-81caa1917dec12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0642-7464BENZNIDAZOLE TABLET [EXELTIS USA, INC.]12Current NDC, Legacy NDC, 2 package rows20250308_8983d6a0-f63f-4f8e-bba4-38223f39e29b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
430551benznidazole 100 MG Oral TabletPSN8983d6a0-f63f-4f8e-bba4-38223f39e29b13
1993222benznidazole 12.5 MG Oral TabletPSN8983d6a0-f63f-4f8e-bba4-38223f39e29b13
430551benznidazole 100 MG Oral TabletSCD8983d6a0-f63f-4f8e-bba4-38223f39e29b13
1993222benznidazole 12.5 MG Oral TabletSCD8983d6a0-f63f-4f8e-bba4-38223f39e29b13
430551benznidazole 100 MG Oral TabletSY8983d6a0-f63f-4f8e-bba4-38223f39e29b13
1993222benznidazole 12.5 MG Oral TabletSY8983d6a0-f63f-4f8e-bba4-38223f39e29b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0642-7464-10006427464101 BOTTLE in 1 CARTON (0642-7464-10) / 100 TABLET in 1 BOTTLE1 bottle2018-03-300000-00-00NoNoCurrent