FDA.reportPublic FDA data

Atovaquone and Proguanil Hydrochloride

Product NDC
42254-150
11-digit product format
422540150
Labeler code
42254
Product ID
42254-150_0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone and Proguanil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA091211
Marketing category
ANDA
Marketing start
2011-08-18
Marketing end
0000-00-00
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-150IInactivated by FDA2026-08-03
excluded packagepackage42254-15042254-150-16IInactivated by FDA2026-08-03
excluded packagepackage42254-15042254-150-24IInactivated by FDA2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12
A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDEATOVAQUONE; PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091211-001AB
A091211-002AB

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 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-10-29 15:01 UTC2024-10A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-1287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-125aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-128869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-123f01610625f2…
2019-12-14 00:12 UTC2019-12A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-063f01610625f2…
2019-09-15 20:21 UTC2019-09A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12b00525d2431f…
2019-09-15 20:21 UTC2019-09A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-12ea99ee380514…
2019-07-19 19:46 UTC2019-07A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-126a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091211-001ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALAB2011-01-121c564ffb4f44…
2024-02-18 07:12 UTC2024-02A091211-002ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALAB2015-04-061c564ffb4f44…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-10-29 15:01 UTC2024-10A091211-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091211-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091211-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091211-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091211-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091211-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091211-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091211-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091211-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091211-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091211-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091211-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091211-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091211-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091211-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091211-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091211-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091211-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091211-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091211-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091211-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091211-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091211-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091211-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091211-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091211-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091211-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091211-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091211-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091211-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091211-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091211-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091211-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091211-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091211-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A091211-002AB11c564ffb4f44…

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
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBryant Ranch Prepacke4ff57f7-07af-4872-ac3a-c521e098ccfe2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEBluePoint Laboratoriesad25ab65-42aa-48f6-b5ed-247f3685d5bf2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
Atovaquone and Proguanil Hydrochloride PediatricATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRICGlenmark Pharmaceuticals Inc.,USA4b80d087-eaa7-448f-967e-344de7f164362026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211
Atovaquone and Proguanil HydrochlorideATOVAQUONE AND PROGUANIL HYDROCHLORIDEProficient Rx LPe74b00fc-8743-4e9d-8a83-aab8e531b3ba2024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091211
application number: ANDA091211

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
42254-150-162019-09-24C16284748780-19350213a-3c1a-c013-e053-90daa90a1393Atovaquone and Proguanil Hydrochloride Tablets
42254-150-242019-09-24C16284748780-19350213a-3c1a-c013-e053-90daa90a1393Atovaquone and Proguanil Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-150-16Atovaquone and Proguanil Hydrochloride16 in 1 BOTTLETABLET161
42254-150-24Atovaquone and Proguanil Hydrochloride24 in 1 BOTTLETABLET241

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-150-16EA - Each42254-1500527feec-7883-4e12-bb5e-b14bd2dfe48312012-07-24
42254-150-24EA - Each42254-1508c2fcefc-634e-4cab-a48c-80387c6363e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-150ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120308_0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b81
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-150-164225401501616 in 1 BOTTLEHistorical
42254-150-244225401502424 in 1 BOTTLEHistorical