Home NDC 51407-869 Atovaquone and Proguanil Hydrochloride
Product NDC 51407-869
11-digit product format 514070869
Labeler code 51407
Product ID 51407-869_45b153c9-e06e-468c-e063-6294a90a2938
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atovaquone and proguanil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA202362
Marketing category ANDA
Marketing start 2014-05-27
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 43 .
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 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27
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 · 86 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 2026-09-14 22:38:34 2026-08 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202362-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2014-05-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202362-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2014-05-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Atovaquone and Proguanil Hydrochloride
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 51407-869-01 Atovaquone and Proguanil Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 2 51407-869-24 Atovaquone and Proguanil Hydrochloride 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-869 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Current NDC, 2 package rows 20240404_152433eb-1341-9cc0-e063-6394a90a1481.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51407-869-01 51407086901 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-01) 2024-04-02 No No Current 51407-869-24 51407086924 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-24) 2024-04-02 No No Current