Atovaquone

Product NDC
73141-104
11-digit product format
731410104
Labeler code
73141
Product ID
73141-104_2abada7d-4115-54ca-e063-6394a90a3d4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
A2A Integrated Pharmaceuticals, LLC
Application
ANDA212918
Marketing category
ANDA
Marketing start
2024-11-29
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73141-104-05Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION52
73141-104-42Atovaquone42 in 1 CARTONSUSPENSION422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73141-104-05ML - Milliliter73141-1049b3e4e25-c903-44d5-a9f1-33313234c62712025-01-14
73141-104-42ML - Milliliter73141-104fa015aac-f275-4ae8-a400-3385df38c7e212025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73141-104ATOVAQUONE SUSPENSION [A2A INTEGRATED PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20250104_27d64592-5078-6122-e063-6394a90ae074.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSN27d64592-5078-6122-e063-6394a90ae0742
308429atovaquone 150 MG/ML Oral SuspensionSCD27d64592-5078-6122-e063-6394a90ae0742
308429atovaquone 1500 MG per 10 ML Oral SuspensionSY27d64592-5078-6122-e063-6394a90ae0742
308429atovaquone 750 MG per 5 ML Oral SuspensionSY27d64592-5078-6122-e063-6394a90ae0742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73141-104-05731410104055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
73141-104-427314101044242 CUP, UNIT-DOSE in 1 CARTON (73141-104-42) / 5 mL in 1 CUP, UNIT-DOSE (73141-104-05) 2024-11-29NoNoCurrent