Atovaquone and Proguanil Hydrochloride

Product NDC: 10544-909
11-digit product format: 105440909
Labeler code: 10544
Product ID: 10544-909_13eef6e5-4535-3009-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atovaquone and Proguanil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA091211
Marketing category: ANDA
Marketing start: 2015-03-19
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-909		I	Inactivated by FDA	2026-08-03
excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	2026-08-03

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 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	10544-909		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-909	10544-909-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-909	10544-909-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

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
10544-909-05	2020-01-31	C162847	48780-1	9d75b9d1-203a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use atovaquone and proguanil hydrochloride tablets safely and effectively. See full prescribing information for atovaquone and proguanil hydrochloride tablets . ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS, for oral administration Initial U.S. Approval: 2000
10544-909-10	2020-01-31	C162847	48780-1	9d75b9d1-203a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use atovaquone and proguanil hydrochloride tablets safely and effectively. See full prescribing information for atovaquone and proguanil hydrochloride tablets . ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS, for oral administration Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-909-05	Atovaquone and Proguanil Hydrochloride	5 in 1 BOTTLE	TABLET, FILM COATED	5		1
10544-909-10	Atovaquone and Proguanil Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-909-05	EA - Each	10544-909	78e7e823-069c-4e5c-8070-8cd8c44d166e	1	2015-12-02
10544-909-10	EA - Each	10544-909	99e197b2-9094-42dc-978b-eaa23d33c0e3	1	2015-12-02

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 [BLENHEIM PHARMACAL, INC.]	1
PROGUANIL HYDROCHLORIDE	ACTIVE INGREDIENT	R71Y86M0WT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
PROGUANIL	ACTIVE MOIETY	S61K3P7B2V	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-909	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 2 package rows	20150417_13eef6e5-4534-3009-e054-00144ff8d46c.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.

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

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	13eef6e5-4534-3009-e054-00144ff8d46c	1
864675	atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet	SCD	13eef6e5-4534-3009-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-909-05	10544090905	5 in 1 BOTTLE	Historical
10544-909-10	10544090910	10 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone and Proguanil Hydrochloride	Blenheim Pharmacal, Inc.	2015-04-17	HUMAN PRESCRIPTION DRUG LABEL	1