FDA.reportPublic FDA data

Atovaquone

Product NDC
62135-528
11-digit product format
621350528
Labeler code
62135
Product ID
62135-528_19392345-2a5f-cbf6-e063-6394a90a61f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA207833
Marketing category
ANDA
Marketing start
2017-04-28
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-528-09Atovaquone210 mL in 1 BOTTLESUSPENSION2102
62135-528-24Atovaquone10 in 1 TRAYSUSPENSION102
62135-528-24Atovaquone2 in 1 BOXSUSPENSION22
62135-528-45Atovaquone5 mL in 1 CUPSUSPENSION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-528-09ML - Milliliter62135-528298ff883-eb83-43b2-b5e6-c848cec081f912023-09-05
62135-528-24ML - Milliliter62135-528977f3e95-075f-45df-b471-f57d020e18e912024-08-12
62135-528-45ML - Milliliter62135-528bb1fd983-9ffd-4499-8955-d5eb71c045bd12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-528ATOVAQUONE SUSPENSION [CHARTWELL RX, LLC]2Current NDC, 4 package rows20240526_de0e29b5-a4c7-405c-a5b9-438729d9ba3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNde0e29b5-a4c7-405c-a5b9-438729d9ba3a2
308429atovaquone 150 MG/ML Oral SuspensionSCDde0e29b5-a4c7-405c-a5b9-438729d9ba3a2
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYde0e29b5-a4c7-405c-a5b9-438729d9ba3a2
308429atovaquone 750 MG per 5 ML Oral SuspensionSYde0e29b5-a4c7-405c-a5b9-438729d9ba3a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-528-0962135052809210 mL in 1 BOTTLE (62135-528-09) 210 ml2023-07-18NoNoHistorical
62135-528-24621350528242 TRAY in 1 BOX (62135-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-528-45) 2 tray2024-05-23NoNoHistorical
62135-528-45621350528455 mL in 1 CUP5 mlHistorical