Atovaquone

Product NDC
70166-488
Requested package NDC
70166-488-05
11-digit product format
701660488
Labeler code
70166
Product ID
70166-488_30ca1c6b-6bc5-3dba-e063-6394a90a5656
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Lohxa
Application
ANDA210692
Marketing category
ANDA
Marketing start
2018-10-11
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70166-48870166-488-05DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210692-001ATOVAQUONEATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210692-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-113f01610625f2…
2019-09-15 20:21 UTC2019-09A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210692-001ATOVAQUONE750MG/5MLSUSPENSION / ORALAB2018-10-11e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210692-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210692-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210692-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210692-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210692-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210692-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210692-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210692-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210692-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210692-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210692-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210692-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210692-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210692-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210692-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210692-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210692-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210692-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210692-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210692-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210692-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210692-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210692-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210692-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210692-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210692-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210692-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210692-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210692-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210692-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210692-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210692-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210692-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210692-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210692-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210692-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210692-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210692-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210692-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210692-001AB1e64feba35796…

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
ba3cad0d-cce9-424f-ba5c-557dba8bef12Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70166-488-05Atovaquone5 mL in 1 CUP, UNIT-DOSESUSPENSION52
70166-488-05Atovaquone50 in 1 CARTONSUSPENSION502
70166-488-10Atovaquone5 mL in 1 SYRINGE, PLASTICSUSPENSION52
70166-488-10Atovaquone30 in 1 CARTONSUSPENSION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-488ATOVAQUONE SUSPENSION [LOHXA]2Current NDC, Legacy NDC, 4 package rows20250327_ba3cad0d-cce9-424f-ba5c-557dba8bef12.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtovaquoneATOVAQUONECamber Pharmaceuticals, Inc.2445304e-4b4e-4358-b098-31f3c49c52ef2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONEAmerican Health Packaging1a8a43a2-bc26-4ee5-aa35-22a5477a71292025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONEATLANTIC BIOLOGICALS CORP.40331de7-819e-5965-e063-6294a90ac91d2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONEATLANTIC BIOLOGICALS CORP.f99a8a0c-2b42-4da0-8f5a-e963fc619e8b2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
AtovaquoneATOVAQUONELohxaba3cad0d-cce9-424f-ba5c-557dba8bef122025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
ndc (package): 70166-488-05
ndc (product): 70166-488
ndc11 (package): 70166048805
AtovaquoneATOVAQUONENorthStar RxLLCfc7bdd97-f780-4eed-80e0-72e70267b21a2024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692
ATOVAQUONEATOVAQUONELupin Pharmaceuticals, Inc.03ddcc33-729c-4d46-ae6b-2ee47978ba162021-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210692
application number: ANDA210692

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 150 MG/ML Oral SuspensionSCDba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYba3cad0d-cce9-424f-ba5c-557dba8bef122
308429atovaquone 750 MG per 5 ML Oral SuspensionSYba3cad0d-cce9-424f-ba5c-557dba8bef122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70166-488-057016604880550 CUP, UNIT-DOSE in 1 CARTON (70166-488-05) > 5 mL in 1 CUP, UNIT-DOSE2018-12-030000-00-00NoNoCurrent