Home NDC 33261-900 Atovaquone and Proguanil Hydrochloride
Product NDC 33261-900
11-digit product format 332610900
Labeler code 33261
Product ID 33261-900_ca6dd35c-a11d-498f-9086-9fd681470743
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atovaquone and Proguanil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA091211
Marketing category ANDA
Marketing start 2011-08-18
Marketing end 0000-00-00
Substance ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength 250 mg/1; mg/1
Pharmacologic classes Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-900-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-900-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-900-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-900-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 33261-900-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 33261-900-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 33261-900-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 33261-900-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 33261-900-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 33261-900-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 33261-900-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 33261-900-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 33261-900-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 33261-900-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 33261-900-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 33261-900-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 33261-900-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 33261-900-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 33261-900-01 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 33261-900-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 33261-900-01 9bebd1f3094a…5416666fcb17…
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 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06
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 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33261-900-01 Atovaquone and Proguanil Hydrochloride 24 in 1 BLISTER PACK TABLET, FILM COATED 24 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATOVAQUONE ACTIVE INGREDIENT Y883P1Z2LT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 PROGUANIL HYDROCHLORIDE ACTIVE INGREDIENT R71Y86M0WT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 ATOVAQUONE ACTIVE MOIETY Y883P1Z2LT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 PROGUANIL ACTIVE MOIETY S61K3P7B2V ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-900 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 1 package rows 20120911_186ad795-f19a-4df6-8f81-b2028a3da229.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33261-900-01 33261090001 24 in 1 BLISTER PACK Historical