FDA.reportPublic FDA data

MALARONE

Product NDC
55289-747
Requested package NDC
55289-747-20
11-digit product format
552890747
Labeler code
55289
Product ID
55289-747_e2382734-ff7e-3075-e053-2995a90a958d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone and proguanil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA021078
Marketing category
NDA
Marketing start
2000-07-26
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 packagepackage55289-74755289-747-20DDiscontinued by firm2026-07-31

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-747-20EA - Each55289-7479d016608-7a31-4226-b6d0-aac681ef0e5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
ATOVAQUONEACTIVE MOIETYY883P1Z2LTMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
PROGUANILACTIVE MOIETYS61K3P7B2VMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-747-205528907472020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-747-20) 2011-12-150000-00-00NoNoCurrent