FDA.reportPublic FDA data

Atovaquone

Product NDC
66689-062
Requested package NDC
66689-062-42
11-digit product format
666890062
Labeler code
66689
Product ID
66689-062_49610dc8-3716-4f7c-a2db-5f7ec9d0838d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
ANDA202960
Marketing category
ANDA
Marketing start
2018-09-14
Marketing end
0000-00-00
Substance
ATOVAQUONE
Active strength
750 mg/5mL
Pharmacologic classes
Antimalarial [EPC],Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66689-06266689-062-42DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202960-001ATOVAQUONEATOVAQUONE750MG/5MLSUSPENSION / ORALAB2014-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202960-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202960-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2014-03-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202960-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATOVAQUONEATOVAQUONEAvKARE54423fee-da60-25dc-e063-6294a90a25522026-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202960
application number: ANDA202960
ATOVAQUONEATOVAQUONEAmneal Pharmaceuticals LLCb7398fcf-522a-488a-8dd6-051561f628042026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202960
application number: ANDA202960
ATOVAQUONEATOVAQUONEAvPAK4124ad97-f6b9-8afb-e063-6294a90ab9702025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202960
application number: ANDA202960

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-062-182024-01-30C16284748780-11030e364-fb63-111a-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 Initial U.S. Approval: 1992
66689-062-422024-01-30C16284748780-11030e364-fb63-111a-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 Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-062-01ML - Milliliter66689-06292d679c4-85a0-44f3-9f95-24304aa289f512018-10-11
66689-062-18ML - Milliliter66689-0622550df72-8f25-4020-9dae-74bc08b11a2e12018-10-11
66689-062-42ML - Milliliter66689-062b547123b-c3a2-4517-a0f8-74977f5d32a112018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-062-426668900624242 POUCH in 1 CASE (66689-062-42) > 1 mL in 1 POUCH (66689-062-01) 42 pouch2018-09-140000-00-00NoNoCurrent