Home NDC 68462-402 Atovaquone and Proguanil Hydrochloride Pediatric
Product NDC 68462-402
11-digit product format 684620402
Labeler code 68462
Product ID 68462-402_a6232b89-d1c0-4114-879d-6c9320a92eb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atovaquone and Proguanil Hydrochloride Pediatric
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc.,USA
Application ANDA091211
Marketing category ANDA
Marketing start 2015-04-08
Substance ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength 62.5; 25 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 Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 12 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68462-402 68462-402-30 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2022-03-09 01:35 UTC 2022-03 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091211-001 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET / ORAL AB 2011-01-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091211-002 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET / ORAL AB 2015-04-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Atovaquone and Proguanil Hydrochloride Pediatric
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOVAQUONE 62.5 mg/1 PROGUANIL HYDROCHLORIDE 25 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864675 Internal RxNorm lookup 864681 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 68462-402-01 Atovaquone and Proguanil Hydrochloride Pediatric 100 in 1 BOTTLE TABLET, FILM COATED 100 14 68462-402-30 Atovaquone and Proguanil Hydrochloride Pediatric 30 in 1 BOTTLE TABLET, FILM COATED 30 14
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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 PROGUANIL HYDROCHLORIDE ACTIVE INGREDIENT R71Y86M0WT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 ATOVAQUONE ACTIVE MOIETY Y883P1Z2LT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 PROGUANIL ACTIVE MOIETY S61K3P7B2V ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-402 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 12 Current NDC, Legacy NDC, 2 package rows 20230111_4b80d087-eaa7-448f-967e-344de7f16436.zip
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 68462-402-01 68462040201 100 TABLET, FILM COATED in 1 BOTTLE (68462-402-01) 2015-04-08 0000-00-00 No No Current 68462-402-30 68462040230 30 in 1 BOTTLE Historical