FDA.reportPublic FDA data

Atovaquone

Product NDC
31722-629
11-digit product format
317220629
Labeler code
31722
Product ID
31722-629_151b9723-5db4-ac2b-e063-6294a90af073
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-629-21Atovaquone1 in 1 CARTONSUSPENSION14
31722-629-21Atovaquone210 mL in 1 BOTTLESUSPENSION2104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-629-21ML - Milliliter31722-62976b9baa6-a740-4cce-bf18-56308bbd4b0a12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-629ATOVAQUONE (ATOVAQUONE) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240403_2445304e-4b4e-4358-b098-31f3c49c52ef.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
308429atovaquone 750 MG in 5 mL Oral SuspensionPSN2445304e-4b4e-4358-b098-31f3c49c52ef4
308429atovaquone 150 MG/ML Oral SuspensionSCD2445304e-4b4e-4358-b098-31f3c49c52ef4
308429atovaquone 1500 MG per 10 ML Oral SuspensionSY2445304e-4b4e-4358-b098-31f3c49c52ef4
308429atovaquone 750 MG per 5 ML Oral SuspensionSY2445304e-4b4e-4358-b098-31f3c49c52ef4
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNf99a8a0c-2b42-4da0-8f5a-e963fc619e8b2
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 150 MG/ML Oral SuspensionSCDf99a8a0c-2b42-4da0-8f5a-e963fc619e8b2
308429atovaquone 150 MG/ML Oral SuspensionSCDba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYf99a8a0c-2b42-4da0-8f5a-e963fc619e8b2
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 750 MG per 5 ML Oral SuspensionSYba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 750 MG per 5 ML Oral SuspensionSYf99a8a0c-2b42-4da0-8f5a-e963fc619e8b2
308429atovaquone 750 MG in 5 mL Oral SuspensionPSN40331de7-819e-5965-e063-6294a90ac91d1
308429atovaquone 150 MG/ML Oral SuspensionSCD40331de7-819e-5965-e063-6294a90ac91d1
308429atovaquone 1500 MG per 10 ML Oral SuspensionSY40331de7-819e-5965-e063-6294a90ac91d1
308429atovaquone 750 MG per 5 ML Oral SuspensionSY40331de7-819e-5965-e063-6294a90ac91d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-629-21317220629211 BOTTLE in 1 CARTON (31722-629-21) / 210 mL in 1 BOTTLE1 bottle2018-10-110000-00-00NoNoCurrent