Home NDC 50090-2980 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 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 Atovaquone and Proguanil HCl
Listing expiration 2026-12-31 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 Y883P1Z2LT Internal UNII lookup R71Y86M0WT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864675 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 50090-2980-0 Atovaquone and Proguanil HCl 7 in 1 BOTTLE TABLET, FILM COATED 7 16 50090-2980-1 Atovaquone and Proguanil HCl 12 in 1 BOTTLE TABLET, FILM COATED 12 16 50090-2980-2 Atovaquone and Proguanil HCl 14 in 1 BOTTLE TABLET, FILM COATED 14 16 50090-2980-3 Atovaquone and Proguanil HCl 16 in 1 BOTTLE TABLET, FILM COATED 16 16 50090-2980-4 Atovaquone and Proguanil HCl 24 in 1 BOTTLE TABLET, FILM COATED 24 16 50090-2980-5 Atovaquone and Proguanil HCl 5 in 1 BOTTLE TABLET, FILM COATED 5 16 50090-2980-6 Atovaquone and Proguanil HCl 10 in 1 BOTTLE TABLET, FILM COATED 10 16 50090-2980-7 Atovaquone and Proguanil HCl 100 in 1 BOTTLE TABLET, FILM COATED 100 16 50090-2980-8 Atovaquone and Proguanil HCl 20 in 1 BOTTLE TABLET, FILM COATED 20 16 50090-2980-9 Atovaquone and Proguanil HCl 30 in 1 BOTTLE TABLET, FILM COATED 30 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2980 ATOVAQUONE AND PROGUANIL HCL (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 16 Current NDC, Legacy NDC, 10 package rows 20231024_593baf3d-bd9e-4a44-8f90-125aa4a7a99e.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 50090-2980-0 50090298000 7 TABLET, FILM COATED in 1 BOTTLE (50090-2980-0) 2017-05-04 0000-00-00 No No Current 50090-2980-1 50090298001 12 TABLET, FILM COATED in 1 BOTTLE (50090-2980-1) 2017-04-27 0000-00-00 No No Current 50090-2980-2 50090298002 14 TABLET, FILM COATED in 1 BOTTLE (50090-2980-2) 2017-05-08 0000-00-00 No No Current 50090-2980-3 50090298003 16 TABLET, FILM COATED in 1 BOTTLE (50090-2980-3) 2017-04-28 0000-00-00 No No Current 50090-2980-4 50090298004 24 TABLET, FILM COATED in 1 BOTTLE (50090-2980-4) 2017-04-21 0000-00-00 No No Current 50090-2980-5 50090298005 5 TABLET, FILM COATED in 1 BOTTLE (50090-2980-5) 2017-04-25 0000-00-00 No No Current 50090-2980-6 50090298006 10 TABLET, FILM COATED in 1 BOTTLE (50090-2980-6) 2017-11-16 0000-00-00 No No Current 50090-2980-7 50090298007 100 TABLET, FILM COATED in 1 BOTTLE (50090-2980-7) 2018-01-17 0000-00-00 No No Current 50090-2980-8 50090298008 20 TABLET, FILM COATED in 1 BOTTLE (50090-2980-8) 2018-02-01 0000-00-00 No No Current 50090-2980-9 50090298009 30 TABLET, FILM COATED in 1 BOTTLE (50090-2980-9) 2018-02-12 0000-00-00 No No Current