FDA.reportPublic FDA data

Atovaquone

Product NDC
42239-001
11-digit product format
422390001
Labeler code
42239
Product ID
42239-001_34f67d35-7080-d493-e063-6294a90a5cc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Abon Pharmaceuticals, LLC
Application
ANDA214272
Marketing category
ANDA
Marketing start
2023-11-14
Substance
ATOVAQUONE
Active strength
750 mg/5mL
Pharmacologic classes
Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOVAQUONE750 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY883P1Z2LT
Rxcui308429

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a3a9d58-de64-b317-9153-f2c3fc3a43c9Product name820220517
7beb5026-9819-5e26-fae7-eca2788430deProduct name220150108
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42239-001-082025-03-14C16284748780-12cef2736-94d9-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ATOVAQUONE ORAL SUSPENSION safely and effectively. See full prescribing information for ATOVAQUONE ORAL SUSPENSION. ATOVAQUONE oral suspension Initial U.S. Approval: 1992
42239-001-082025-01-30C16284748780-12cef2736-94d9-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ATOVAQUONE ORAL SUSPENSION safely and effectively. See full prescribing information for ATOVAQUONE ORAL SUSPENSION. ATOVAQUONE oral suspension Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42239-001-08Atovaquone1 in 1 CARTONSUSPENSION112
42239-001-08Atovaquone210 mL in 1 BOTTLESUSPENSION21012
42239-001-17Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION512
42239-001-66Atovaquone6 in 1 TRAYSUSPENSION612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42239-001ATOVAQUONE SUSPENSION [ABON PHARMACEUTICALS, LLC]12Current NDC, 4 package rows20250514_2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSN2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd0812
308429atovaquone 150 MG/ML Oral SuspensionSCD2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd0812
308429atovaquone 1500 MG per 10 ML Oral SuspensionSY2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd0812
308429atovaquone 750 MG per 5 ML Oral SuspensionSY2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd0812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42239-001-08422390001081 BOTTLE in 1 CARTON (42239-001-08) / 210 mL in 1 BOTTLE1 bottle2023-11-14NoNoHistorical
42239-001-17422390001175 mL in 1 CUP, UNIT-DOSE5 mlHistorical
42239-001-66422390001666 CUP, UNIT-DOSE in 1 TRAY (42239-001-66) / 5 mL in 1 CUP, UNIT-DOSE (42239-001-17) 2025-05-01NoNoHistorical