FDA.reportPublic FDA data

Atovaquone

Product NDC
0121-0956
11-digit product format
001210956
Labeler code
0121
Product ID
0121-0956_0145c97d-2d5e-4fcd-ae76-85e4ae946350
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA214272
Marketing category
ANDA
Marketing start
2025-04-04
Substance
ATOVAQUONE
Active strength
750 mg/5mL
Pharmacologic classes
Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A214272-001ATOVAQUONEATOVAQUONE750MG/5MLSUSPENSION / ORALAB2021-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214272-001AB

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 22:54:322026-06A214272-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2021-10-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214272-001AB1a50c72e98297…

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
AtovaquoneATOVAQUONEPAI Holdings, LLC dba PAI Pharmadf6086d3-6100-422a-bf23-e9610027749b2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214272
application number: ANDA214272
ndc (product): 0121-0956
ATOVAQUONEATOVAQUONE ORAL SUSPENSIONMajor Pharmaceuticals73e2297e-7cda-4abf-9fb7-8c67cb5638a32025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214272
application number: ANDA214272
AtovaquoneATOVAQUONEAbon Pharmaceuticals, LLC2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd082025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214272
application number: ANDA214272

Additional Listing Data#

Finished product
Yes
Brand name base
Atovaquone
Listing expiration
2027-12-31

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
df6086d3-6100-422a-bf23-e9610027749bAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0956-08Atovaquone210 mL in 1 BOTTLESUSPENSION21013
0121-0956-08Atovaquone1 in 1 CARTONSUSPENSION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0956-08ML - Milliliter0121-0956548c8b5e-9b7d-4e15-85fd-9e0b719af56712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0956ATOVAQUONE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]12Current NDC, 2 package rows20250406_df6086d3-6100-422a-bf23-e9610027749b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNdf6086d3-6100-422a-bf23-e9610027749b13
308429atovaquone 150 MG/ML Oral SuspensionSCDdf6086d3-6100-422a-bf23-e9610027749b13
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYdf6086d3-6100-422a-bf23-e9610027749b13
308429atovaquone 750 MG per 5 ML Oral SuspensionSYdf6086d3-6100-422a-bf23-e9610027749b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-0956-08001210956081 BOTTLE in 1 CARTON (0121-0956-08) / 210 mL in 1 BOTTLE1 bottle2025-04-04NoNoCurrent