FDA.reportPublic FDA data

Atovaquone

Product NDC
81033-104
11-digit product format
810330104
Labeler code
81033
Product ID
81033-104_3edaf9cd-76b2-a531-e063-6294a90a7e1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kesin Pharma
Application
ANDA212918
Marketing category
ANDA
Marketing start
2024-06-17
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

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
A212918-001ATOVAQUONEATOVAQUONE750MG/5MLSUSPENSION / ORALAB2021-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212918-001AB

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 22:54:322026-06A212918-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2021-03-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212918-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtovaquoneATOVAQUONEGolden State Medical Supply, Inc.ddbfe1a9-df9b-79b0-e053-2995a90acc9b2025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212918
application number: ANDA212918
AtovaquoneATOVAQUONEBionpharma Inc.bff4f4fc-6307-f414-e053-2a95a90ac0de2025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212918
application number: ANDA212918
AtovaquoneATOVAQUONEKesin Pharma16b69156-e5de-c601-e063-6394a90afeae2025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212918
application number: ANDA212918
ndc (product): 81033-104
AtovaquoneATOVAQUONEA2A Integrated Pharmaceuticals, LLC27d64592-5078-6122-e063-6394a90ae0742025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212918
application number: ANDA212918

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Y883P1Z2LTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308429Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
16b69156-e5de-c601-e063-6394a90afeaeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a3a9d58-de64-b317-9153-f2c3fc3a43c9Product name820220517
7beb5026-9819-5e26-fae7-eca2788430deProduct name220150108
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-104-05Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION55
81033-104-22Atovaquone20 in 1 CARTONSUSPENSION205
81033-104-42Atovaquone42 in 1 CARTONSUSPENSION425
81033-104-50Atovaquone50 in 1 CARTONSUSPENSION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-104-05ML - Milliliter81033-104c018edbe-f696-48dc-892d-d7f7065758a712024-10-04
81033-104-22ML - Milliliter81033-1041ef5ddc5-193e-4226-885e-1840aee1234e12025-10-14
81033-104-42ML - Milliliter81033-1044c08e487-0466-489b-bf78-671ea706112b12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-104ATOVAQUONE SUSPENSION [KESIN PHARMA]4Current NDC, 4 package rows20241207_16b69156-e5de-c601-e063-6394a90afeae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSN16b69156-e5de-c601-e063-6394a90afeae5
308429atovaquone 150 MG/ML Oral SuspensionSCD16b69156-e5de-c601-e063-6394a90afeae5
308429atovaquone 1500 MG per 10 ML Oral SuspensionSY16b69156-e5de-c601-e063-6394a90afeae5
308429atovaquone 750 MG per 5 ML Oral SuspensionSY16b69156-e5de-c601-e063-6394a90afeae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-104-05810330104055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-104-228103301042220 CUP, UNIT-DOSE in 1 CARTON (81033-104-22) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05) 2025-09-15NoNoCurrent
81033-104-428103301044242 CUP, UNIT-DOSE in 1 CARTON (81033-104-42) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05) 2024-06-17NoNoCurrent
81033-104-508103301045050 CUP, UNIT-DOSE in 1 CARTON (81033-104-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05) 2024-06-17NoNoCurrent