FDA.reportPublic FDA data

Atovaquone and Proguanil HCl

Product NDC
63629-5531
Requested package NDC
63629-5531-4
11-digit product format
636295531
Labeler code
63629
Product ID
63629-5531_42154701-f14c-4b9e-84f4-c6152c56b3ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone and proguanil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021078
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-07-27
Marketing end
0000-00-00
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage63629-553163629-5531-4IInactivated by FDA2026-07-31

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
N021078-001MALARONEATOVAQUONE; PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALABRLD, RS2000-07-14
N021078-002MALARONE PEDIATRICATOVAQUONE; PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALABRLD2000-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021078-001AB
N021078-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14a50c72e98297…
2026-08-01 22:54:322026-06N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021078-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021078-002AB1a50c72e98297…

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
MALARONEATOVAQUONE AND PROGUANIL HYDROCHLORIDEGlaxoSmithKline LLCfc22e8d8-3bfb-4f70-a599-dd81262a48872026-06-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078
Atovaquone and Proguanil HClATOVAQUONE AND PROGUANIL HYDROCHLORIDEA-S Medication Solutions593baf3d-bd9e-4a44-8f90-125aa4a7a99e2023-10-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078
Atovaquone and Proguanil HClATOVAQUONE AND PROGUANIL HYDROCHLORIDEPrasco Laboratories7069521a-c7f9-4e8d-99b8-0cb5c971e7cf2022-05-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078

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
63629-5531-12024-01-30C16284748780-11030e365-58c0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tablets Initial U.S. Approval: 2000
63629-5531-22024-01-30C16284748780-11030e365-58c0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tablets Initial U.S. Approval: 2000
63629-5531-32024-01-30C16284748780-11030e365-58c0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tablets Initial U.S. Approval: 2000
63629-5531-42024-01-30C16284748780-11030e365-58c0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tablets Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5531-1Atovaquone and Proguanil HCl10 in 1 BOTTLETABLET, FILM COATED101007
63629-5531-2Atovaquone and Proguanil HCl24 in 1 BOTTLETABLET, FILM COATED241007
63629-5531-3Atovaquone and Proguanil HCl5 in 1 BOTTLETABLET, FILM COATED51007
63629-5531-4Atovaquone and Proguanil HCl12 in 1 BOTTLETABLET, FILM COATED121007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ATOVAQUONEACTIVE MOIETYY883P1Z2LTATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
PROGUANILACTIVE MOIETYS61K3P7B2VATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5531ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1007Legacy NDC, 4 package rows20220702_7d124c6f-dbdb-48ee-8fd2-9880fdf9d765.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN7d124c6f-dbdb-48ee-8fd2-9880fdf9d7651007
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD7d124c6f-dbdb-48ee-8fd2-9880fdf9d7651007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5531-46362955310412 TABLET, FILM COATED in 1 BOTTLE (63629-5531-4) 2021-12-220000-00-00NoNoCurrent