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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68258-1104		I	Inactivated by FDA	2026-08-03
excluded package	package	68258-1104	68258-1104-3	I	Inactivated by FDA	2026-08-03
excluded package	package	68258-1104	68258-1104-4	I	Inactivated by FDA	2026-08-03
excluded package	package	68258-1104	68258-1104-5	I	Inactivated by FDA	2026-08-03
excluded package	package	68258-1104	68258-1104-6	I	Inactivated by FDA	2026-08-03
excluded package	package	68258-1104	68258-1104-7	I	Inactivated by FDA	2026-08-03
excluded package	package	68258-1104	68258-1104-9	I	Inactivated by FDA	2026-08-03

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 · 28 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	Archive	Snapshot	Source SHA-256
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	68258-1104		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-1104	68258-1104-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-1104	68258-1104-7	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-1104	68258-1104-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-1104	68258-1104-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-1104	68258-1104-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-1104	68258-1104-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	68258-1104		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-1104	68258-1104-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-1104	68258-1104-7	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-1104	68258-1104-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-1104	68258-1104-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-1104	68258-1104-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-1104	68258-1104-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	68258-1104		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-1104	68258-1104-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-1104	68258-1104-7	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-1104	68258-1104-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-1104	68258-1104-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-1104	68258-1104-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-1104	68258-1104-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	68258-1104		I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-1104	68258-1104-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-1104	68258-1104-7	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-1104	68258-1104-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-1104	68258-1104-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-1104	68258-1104-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-1104	68258-1104-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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.

Application-product, TE code table
Application-product	TE code
A091211-001	AB
A091211-002	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091211-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091211-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091211-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091211-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091211-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091211-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091211-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091211-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091211-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091211-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091211-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091211-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091211-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091211-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091211-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091211-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091211-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091211-002	AB	1	`782e0a99824c…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	Bryant Ranch Prepack	e4ff57f7-07af-4872-ac3a-c521e098ccfe	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	BluePoint Laboratories	ad25ab65-42aa-48f6-b5ed-247f3685d5bf	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride Pediatric	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC	Glenmark Pharmaceuticals Inc.,USA	4b80d087-eaa7-448f-967e-344de7f16436	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	Proficient Rx LP	e74b00fc-8743-4e9d-8a83-aab8e531b3ba	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4a3a9d58-de64-b317-9153-f2c3fc3a43c9	Product name	8	20220517
7beb5026-9819-5e26-fae7-eca2788430de	Product name	2	20150108

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-1104-3	2019-11-27	C162847	48780-1	9855d018-e783-cd31-e053-dbdaa90ab51a	Atovaquone and Proguanil Hydrochloride Tablets
68258-1104-4	2019-11-27	C162847	48780-1	9855d018-e783-cd31-e053-dbdaa90ab51a	Atovaquone and Proguanil Hydrochloride Tablets
68258-1104-5	2019-11-27	C162847	48780-1	9855d018-e783-cd31-e053-dbdaa90ab51a	Atovaquone and Proguanil Hydrochloride Tablets
68258-1104-6	2019-11-27	C162847	48780-1	9855d018-e783-cd31-e053-dbdaa90ab51a	Atovaquone and Proguanil Hydrochloride Tablets
68258-1104-7	2019-11-27	C162847	48780-1	9855d018-e783-cd31-e053-dbdaa90ab51a	Atovaquone and Proguanil Hydrochloride Tablets
68258-1104-9	2019-11-27	C162847	48780-1	9855d018-e783-cd31-e053-dbdaa90ab51a	Atovaquone and Proguanil Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68258-1104-3	EA - Each	68258-1104	a9cb04ae-ba34-4bc1-96ca-7d4f8a5308a3	1	2013-10-17
68258-1104-4	EA - Each	68258-1104	f12c154d-b29a-4316-b868-4bf4c3a4dbcc	1	2013-10-17
68258-1104-5	EA - Each	68258-1104	1e482605-1d95-44fc-a036-98116df07312	1	2013-10-17
68258-1104-6	EA - Each	68258-1104	609d7796-b534-4e3c-b3b4-7a637bbc7b2c	1	2013-10-17
68258-1104-7	EA - Each	68258-1104	53c8fa1f-3753-46ce-a184-69e4b8adb8e4	1	2013-10-17
68258-1104-9	EA - Each	68258-1104	dd13e833-d999-47d4-8f31-3349e5a6a38b	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y883P1Z2LT	ATOVAQUONE	95233-18-4	ATOVAQUONE
R71Y86M0WT	PROGUANIL HYDROCHLORIDE	637-32-1	PROGUANIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
864675	atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet	PSN	f8659107-ef6b-4142-a4b8-6934aae07f41	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	f8659107-ef6b-4142-a4b8-6934aae07f41	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone and Proguanil Hydrochloride Tablets	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-08-23	HUMAN PRESCRIPTION DRUG LABEL	1