FDA.reportPublic FDA data

Atovaquone and Proguanil HCl

Product NDC
50090-2980
11-digit product format
500902980
Labeler code
50090
Product ID
50090-2980_db61f577-1818-4643-8712-23db5c162ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone and proguanil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021078
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-07-27
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250; 100 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
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 · 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
ndc (product): 50090-2980
Atovaquone and Proguanil HClATOVAQUONE AND PROGUANIL HYDROCHLORIDEPrasco Laboratories7069521a-c7f9-4e8d-99b8-0cb5c971e7cf2022-05-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078

Additional Listing Data#

Finished product
Yes
Brand name base
Atovaquone and Proguanil HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOVAQUONE250 mg/1
PROGUANIL HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Y883P1Z2LTInternal UNII lookup
R71Y86M0WTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
593baf3d-bd9e-4a44-8f90-125aa4a7a99eAvailable 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
50090-2980-0Atovaquone and Proguanil HCl7 in 1 BOTTLETABLET, FILM COATED716
50090-2980-1Atovaquone and Proguanil HCl12 in 1 BOTTLETABLET, FILM COATED1216
50090-2980-2Atovaquone and Proguanil HCl14 in 1 BOTTLETABLET, FILM COATED1416
50090-2980-3Atovaquone and Proguanil HCl16 in 1 BOTTLETABLET, FILM COATED1616
50090-2980-4Atovaquone and Proguanil HCl24 in 1 BOTTLETABLET, FILM COATED2416
50090-2980-5Atovaquone and Proguanil HCl5 in 1 BOTTLETABLET, FILM COATED516
50090-2980-6Atovaquone and Proguanil HCl10 in 1 BOTTLETABLET, FILM COATED1016
50090-2980-7Atovaquone and Proguanil HCl100 in 1 BOTTLETABLET, FILM COATED10016
50090-2980-8Atovaquone and Proguanil HCl20 in 1 BOTTLETABLET, FILM COATED2016
50090-2980-9Atovaquone and Proguanil HCl30 in 1 BOTTLETABLET, FILM COATED3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2980-0EA - Each50090-29807cee64de-d3a2-49c4-8540-6edcd9edf0c312018-10-11
50090-2980-1EA - Each50090-29801b13bc45-86c3-4200-bf91-1a0f674eae1512018-10-11
50090-2980-2EA - Each50090-2980039d97fe-1171-4afb-a567-89df693b730312018-10-11
50090-2980-3EA - Each50090-29808fb7bcc3-d677-4493-9f39-31ce7bfd318312019-05-02
50090-2980-4EA - Each50090-2980ee8543ed-1b4d-4d31-b266-d5f4650d4f3912019-05-02
50090-2980-5EA - Each50090-2980f9684ae2-6a10-4dfc-b855-bdfe4cc120b012019-05-02
50090-2980-6EA - Each50090-29805e6243c4-adfd-45c6-9343-b2928fd6a21e12019-05-02
50090-2980-7EA - Each50090-29806b2ea349-daab-4128-a8f2-28ac76af151a12019-05-02
50090-2980-8EA - Each50090-29803d2934e0-efd4-4559-9233-0955a406072612019-05-02
50090-2980-9EA - Each50090-2980405ecab9-d9f9-4ba5-8152-33413369834112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2980ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 10 package rows20231024_593baf3d-bd9e-4a44-8f90-125aa4a7a99e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN593baf3d-bd9e-4a44-8f90-125aa4a7a99e16
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD593baf3d-bd9e-4a44-8f90-125aa4a7a99e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2980-0500902980007 TABLET, FILM COATED in 1 BOTTLE (50090-2980-0) 2017-05-040000-00-00NoNoCurrent
50090-2980-15009029800112 TABLET, FILM COATED in 1 BOTTLE (50090-2980-1) 2017-04-270000-00-00NoNoCurrent
50090-2980-25009029800214 TABLET, FILM COATED in 1 BOTTLE (50090-2980-2) 2017-05-080000-00-00NoNoCurrent
50090-2980-35009029800316 TABLET, FILM COATED in 1 BOTTLE (50090-2980-3) 2017-04-280000-00-00NoNoCurrent
50090-2980-45009029800424 TABLET, FILM COATED in 1 BOTTLE (50090-2980-4) 2017-04-210000-00-00NoNoCurrent
50090-2980-5500902980055 TABLET, FILM COATED in 1 BOTTLE (50090-2980-5) 2017-04-250000-00-00NoNoCurrent
50090-2980-65009029800610 TABLET, FILM COATED in 1 BOTTLE (50090-2980-6) 2017-11-160000-00-00NoNoCurrent
50090-2980-750090298007100 TABLET, FILM COATED in 1 BOTTLE (50090-2980-7) 2018-01-170000-00-00NoNoCurrent
50090-2980-85009029800820 TABLET, FILM COATED in 1 BOTTLE (50090-2980-8) 2018-02-010000-00-00NoNoCurrent
50090-2980-95009029800930 TABLET, FILM COATED in 1 BOTTLE (50090-2980-9) 2018-02-120000-00-00NoNoCurrent