Home NDC 0173-0675 MALARONE
Product NDC 0173-0675
11-digit product format 001730675
Labeler code 0173
Product ID 0173-0675_39349dbb-ccca-45a2-bc2b-8bd69602d7b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atovaquone and proguanil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA021078
Marketing category NDA
Marketing start 2000-07-26
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 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021078-001 MALARONE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 N021078-002 MALARONE PEDIATRIC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021078-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N021078-002 AB 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base MALARONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOVAQUONE 250 mg/1 PROGUANIL HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R71Y86M0WT Internal UNII lookup Y883P1Z2LT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864675 Internal RxNorm lookup 864679 Internal RxNorm lookup 864681 Internal RxNorm lookup 864685 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0173-0675-01 MALARONE 100 in 1 BOTTLE TABLET, FILM COATED 100 30 0173-0675-02 MALARONE 24 in 1 DOSE PACK TABLET, FILM COATED 24 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATOVAQUONE ACTIVE INGREDIENT Y883P1Z2LT MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 PROGUANIL HYDROCHLORIDE ACTIVE INGREDIENT R71Y86M0WT MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 ATOVAQUONE ACTIVE MOIETY Y883P1Z2LT MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 PROGUANIL ACTIVE MOIETY S61K3P7B2V MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 ATOVAQUONE ACTIVE INGREDIENT Y883P1Z2LT MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 PROGUANIL HYDROCHLORIDE ACTIVE INGREDIENT R71Y86M0WT MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 ATOVAQUONE ACTIVE MOIETY Y883P1Z2LT MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 PROGUANIL ACTIVE MOIETY S61K3P7B2V MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0173-0675 MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 28 Current NDC, Legacy NDC, 2 package rows 20240711_fc22e8d8-3bfb-4f70-a599-dd81262a4887.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0173-0675-01 00173067501 100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01) 2000-07-26 0000-00-00 No No Current 0173-0675-02 00173067502 24 TABLET, FILM COATED in 1 DOSE PACK (0173-0675-02) 2000-07-26 0000-00-00 No No Current