Home NDC 68258-1104 Atovaquone and Proguanil Hydrochloride
Product NDC 68258-1104
11-digit product format 682581104
Labeler code 68258
Product ID 68258-1104_0f8b0d18-94a9-4e99-a354-0f0fc40039dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atovaquone and Proguanil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dispensing Solutions, Inc.
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 E
Listing certified through 2017-12-31
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 3 · 154 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 68258-1104-3 Atovaquone and Proguanil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 1 68258-1104-4 Atovaquone and Proguanil Hydrochloride 4 in 1 BOTTLE TABLET, FILM COATED 4 1 68258-1104-5 Atovaquone and Proguanil Hydrochloride 5 in 1 BOTTLE TABLET, FILM COATED 5 1 68258-1104-6 Atovaquone and Proguanil Hydrochloride 16 in 1 BOTTLE TABLET, FILM COATED 16 1 68258-1104-7 Atovaquone and Proguanil Hydrochloride 7 in 1 PACKAGE TABLET, FILM COATED 7 1 68258-1104-9 Atovaquone and Proguanil Hydrochloride 9 in 1 PACKAGE TABLET, FILM COATED 9 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 [DISPENSING SOLUTIONS, INC.] 1 PROGUANIL HYDROCHLORIDE ACTIVE INGREDIENT R71Y86M0WT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 ATOVAQUONE ACTIVE MOIETY Y883P1Z2LT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 PROGUANIL ACTIVE MOIETY S61K3P7B2V ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68258-1104 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 6 package rows 20130823_f8659107-ef6b-4142-a4b8-6934aae07f41.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 68258-1104-3 68258110403 30 in 1 BOTTLE Historical 68258-1104-4 68258110404 4 in 1 BOTTLE Historical 68258-1104-5 68258110405 5 in 1 BOTTLE Historical 68258-1104-6 68258110406 16 in 1 BOTTLE Historical 68258-1104-7 68258110407 7 in 1 PACKAGE Historical 68258-1104-9 68258110409 9 in 1 PACKAGE Historical