FDA.reportPublic FDA data

Atovaquone Oral Suspension

Product NDC
10702-223
11-digit product format
107020223
Labeler code
10702
Product ID
10702-223_116f0b5b-cbad-8216-e063-6294a90a9a13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA210510
Marketing category
ANDA
Marketing start
2019-03-29
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 Oral Suspension
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
10702-223-212024-02-15C16284748780-11030e365-5dcf-111a-e063-dadaa90a10e2These 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, for oral use Initial U.S. Approval: 1992
10702-223-212024-01-30C16284748780-11030e365-5dcf-111a-e063-dadaa90a10e2These 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, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-223-21Atovaquone Oral Suspension1 in 1 CARTONSUSPENSION17
10702-223-21Atovaquone Oral Suspension210 mL in 1 BOTTLE, PLASTICSUSPENSION2107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-223-21ML - Milliliter10702-2234e794d89-5fa2-45e7-9a2b-3d808fb0a44212019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-223ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE) SUSPENSION [KVK-TECH, INC.]7Current NDC, Legacy NDC, 2 package rows20240217_b31ff20a-c363-4be0-9bc0-3081c163b63c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNb31ff20a-c363-4be0-9bc0-3081c163b63c7
308429atovaquone 150 MG/ML Oral SuspensionSCDb31ff20a-c363-4be0-9bc0-3081c163b63c7
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYb31ff20a-c363-4be0-9bc0-3081c163b63c7
308429atovaquone 750 MG per 5 ML Oral SuspensionSYb31ff20a-c363-4be0-9bc0-3081c163b63c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-223-21107020223211 BOTTLE, PLASTIC in 1 CARTON (10702-223-21) / 210 mL in 1 BOTTLE, PLASTIC2019-03-290000-00-00NoNoCurrent