Atovaquone

Product NDC
72603-248
11-digit product format
726030248
Labeler code
72603
Product ID
72603-248_15e36ffa-2f19-ac0a-e063-6394a90afe22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA210692
Marketing category
ANDA
Marketing start
2024-05-01
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
72603-248-01Atovaquone1 in 1 CARTONSUSPENSION11
72603-248-01Atovaquone210 mL in 1 BOTTLESUSPENSION2101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-248-01ML - Milliliter72603-2487072ee19-64f9-41d6-a516-24cb97eee17b12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-248ATOVAQUONE (ATOVAQUONE) SUSPENSION [NORTHSTAR RXLLC]1Current NDC, 2 package rows20240501_fc7bdd97-f780-4eed-80e0-72e70267b21a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNfc7bdd97-f780-4eed-80e0-72e70267b21a1
308429atovaquone 150 MG/ML Oral SuspensionSCDfc7bdd97-f780-4eed-80e0-72e70267b21a1
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYfc7bdd97-f780-4eed-80e0-72e70267b21a1
308429atovaquone 750 MG per 5 ML Oral SuspensionSYfc7bdd97-f780-4eed-80e0-72e70267b21a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-248-01726030248011 BOTTLE in 1 CARTON (72603-248-01) / 210 mL in 1 BOTTLE1 bottle2024-05-01NoNoHistorical