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 42 .
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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021078-001 MALARONE 250MG;100MG TABLET / ORAL AB RLD, RS 2000-07-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021078-002 MALARONE PEDIATRIC 62.5MG;25MG TABLET / ORAL AB RLD 2000-07-14 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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