Home NDC 68001-245 Atovaquone and Proguanil Hydrochloride
Product NDC 68001-245
11-digit product format 680010245
Labeler code 68001
Product ID 68001-245_5a928626-0b3c-9a9b-e063-6394a90a6adc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atovaquone and Proguanil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BluePoint Laboratories
Application ANDA091211
Marketing category ANDA
Marketing start 2014-03-13
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 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.
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 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 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 68001-245-00 Atovaquone and Proguanil Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 8 68001-245-14 Atovaquone and Proguanil Hydrochloride 12 in 1 BLISTER PACK TABLET, FILM COATED 12 8 68001-245-15 Atovaquone and Proguanil Hydrochloride 2 in 1 CARTON TABLET, FILM COATED 2 8
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 [BLUEPOINT LABORATORIES] 3 PROGUANIL HYDROCHLORIDE ACTIVE INGREDIENT R71Y86M0WT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 ATOVAQUONE ACTIVE MOIETY Y883P1Z2LT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 PROGUANIL ACTIVE MOIETY S61K3P7B2V ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-245 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] 7 Current NDC, Legacy NDC, 3 package rows 20221217_ad25ab65-42aa-48f6-b5ed-247f3685d5bf.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 Units Marketing start Marketing end Sample Exclude flag Status 68001-245-00 68001024500 100 TABLET, FILM COATED in 1 BOTTLE (68001-245-00) 2014-03-13 0000-00-00 No No Current 68001-245-14 68001024514 12 in 1 BLISTER PACK Historical 68001-245-15 68001024515 2 BLISTER PACK in 1 CARTON (68001-245-15) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68001-245-14) 2 blister pack 2014-03-13 0000-00-00 No No Current