Atovaquone

Product NDC
51407-642
11-digit product format
514070642
Labeler code
51407
Product ID
51407-642_462baf59-9901-aed4-e063-6394a90af61a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA212918
Marketing category
ANDA
Marketing start
2021-03-30
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
51407-642-87Atovaquone210 mL in 1 BOTTLESUSPENSION2104
51407-642-87Atovaquone1 in 1 CARTONSUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-642-87ML - Milliliter51407-642aa54f574-5455-4406-95b4-62caf2ba250d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-642ATOVAQUONE SUSPENSION [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, Legacy NDC, 2 package rows20240302_ddbfe1a9-df9b-79b0-e053-2995a90acc9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNddbfe1a9-df9b-79b0-e053-2995a90acc9b4
308429atovaquone 150 MG/ML Oral SuspensionSCDddbfe1a9-df9b-79b0-e053-2995a90acc9b4
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYddbfe1a9-df9b-79b0-e053-2995a90acc9b4
308429atovaquone 750 MG per 5 ML Oral SuspensionSYddbfe1a9-df9b-79b0-e053-2995a90acc9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-642-87514070642871 BOTTLE in 1 CARTON (51407-642-87) / 210 mL in 1 BOTTLE1 bottle2022-03-140000-00-00NoNoCurrent