FDA.reportPublic FDA data

Atovaquone

Product NDC
70166-488
11-digit product format
701660488
Labeler code
70166
Product ID
70166-488_30ca1c6b-6bc5-3dba-e063-6394a90a5656
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Lohxa
Application
ANDA210692
Marketing category
ANDA
Marketing start
2018-10-11
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70166-488-052025-03-25C16284748780-1f386c64a-4832-0266-e053-dadaa90a7c1aThese 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
70166-488-102025-03-25C16284748780-1f386c64a-4832-0266-e053-dadaa90a7c1aThese 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
70166-488-052023-01-30C16284748780-1f386c64a-4832-0266-e053-dadaa90a7c1aThese 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
70166-488-102023-01-30C16284748780-1f386c64a-4832-0266-e053-dadaa90a7c1aThese 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
70166-488-05Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION52
70166-488-05Atovaquone50 in 1 CARTONSUSPENSION502
70166-488-10Atovaquone5 mL in 1 SYRINGE, PLASTICSUSPENSION52
70166-488-10Atovaquone30 in 1 CARTONSUSPENSION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-488ATOVAQUONE SUSPENSION [LOHXA]2Current NDC, Legacy NDC, 4 package rows20250327_ba3cad0d-cce9-424f-ba5c-557dba8bef12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 150 MG/ML Oral SuspensionSCDba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 750 MG per 5 ML Oral SuspensionSYba3cad0d-cce9-424f-ba5c-557dba8bef122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70166-488-057016604880550 CUP, UNIT-DOSE in 1 CARTON (70166-488-05) > 5 mL in 1 CUP, UNIT-DOSE2018-12-030000-00-00NoNoCurrent
70166-488-107016604881030 SYRINGE, PLASTIC in 1 CARTON (70166-488-10) > 5 mL in 1 SYRINGE, PLASTIC2018-12-030000-00-00NoNoCurrent