FDA.reportPublic FDA data

Atovaquone

Product NDC
60687-534
11-digit product format
606870534
Labeler code
60687
Product ID
60687-534_415fac59-7480-cad1-e063-6394a90ad7ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA210692
Marketing category
ANDA
Marketing start
2020-10-21
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
60687-534-36Atovaquone2 in 1 CASESUSPENSION25
60687-534-40Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION55
60687-534-46Atovaquone10 in 1 TRAYSUSPENSION105
60687-534-52Atovaquone6 in 1 TRAYSUSPENSION65
60687-534-78Atovaquone7 in 1 CASESUSPENSION75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-534-36ML - Milliliter60687-5343ea661a2-79a0-4a7c-9635-4eef137913ee12023-07-06
60687-534-46ML - Milliliter60687-534a56839d8-02db-4d16-90f5-afa1ce6f8baf12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-534ATOVAQUONE SUSPENSION [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 5 package rows20230811_1a8a43a2-bc26-4ee5-aa35-22a5477a7129.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSN1a8a43a2-bc26-4ee5-aa35-22a5477a71295
308429atovaquone 150 MG/ML Oral SuspensionSCD1a8a43a2-bc26-4ee5-aa35-22a5477a71295
308429atovaquone 1500 MG per 10 ML Oral SuspensionSY1a8a43a2-bc26-4ee5-aa35-22a5477a71295
308429atovaquone 750 MG per 5 ML Oral SuspensionSY1a8a43a2-bc26-4ee5-aa35-22a5477a71295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-534-36606870534362 TRAY in 1 CASE (60687-534-36) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-534-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40) 2 tray2023-07-13NoNoHistorical
60687-534-40606870534405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-534-466068705344610 in 1 TRAYHistorical
60687-534-52606870534526 in 1 TRAYHistorical
60687-534-78606870534787 TRAY in 1 CASE (60687-534-78) / 6 CUP, UNIT-DOSE in 1 TRAY (60687-534-52) / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40) 7 tray2020-10-210000-00-00NoNoCurrent