Atovaquone and Proguanil Hydrochloride

Product NDC: 50090-1302
11-digit product format: 500901302
Labeler code: 50090
Product ID: 50090-1302_ca4d8825-068f-4f73-b1ad-4f012cd53832
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atovaquone and Proguanil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA091211
Marketing category: ANDA
Marketing start: 2011-09-15
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: No
Listing certified through: 2022-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-1302		D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-0	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-1	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-2	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-3	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-4	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-5	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-6	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-7	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-8	D	Discontinued by firm	2026-08-03
excluded package	package	50090-1302	50090-1302-9	D	Discontinued by firm	2026-08-03

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1302-0	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-1	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-2	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-3	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-4	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-5	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-6	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-7	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-8	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-9	2023-02-06	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-0	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-1	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-2	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-3	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-4	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-5	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-6	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-7	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-8	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000
50090-1302-9	2023-01-30	C162847	48780-1	f386c64a-0eab-0266-e053-dadaa90a7c1a	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 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE pediatric tablets, for oral administration Initial U.S. Approval: 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1302-0	EA - Each	50090-1302	7ad09f1b-fb70-4d9c-9f21-277668805a66	1	2018-11-06
50090-1302-1	EA - Each	50090-1302	543e5732-13f0-4f07-9f56-faaea6156d24	1	2018-11-06
50090-1302-2	EA - Each	50090-1302	c692be7e-5da9-4784-ae43-acc47b3870eb	1	2018-11-06
50090-1302-3	EA - Each	50090-1302	3173a86c-b4e4-4f6c-a589-b6bd0c55b7a6	1	2018-11-06
50090-1302-4	EA - Each	50090-1302	7f6535f0-5e5f-4809-a5a0-5caa2c78337f	1	2018-11-06
50090-1302-5	EA - Each	50090-1302	fa3f2b94-ea9d-4c91-a435-a54ce5f949e5	1	2018-11-06
50090-1302-6	EA - Each	50090-1302	72d9cbcf-0411-4fe0-897d-084ace46654f	1	2018-11-06
50090-1302-7	EA - Each	50090-1302	6f1c8d2a-0ea6-45ca-9c87-69f6e35e13c1	1	2018-11-06
50090-1302-8	EA - Each	50090-1302	85a7f6de-3f39-4e18-b944-a83c13554b63	1	2018-11-06
50090-1302-9	EA - Each	50090-1302	e093c698-f3b0-4978-93a1-b6f7e5ea6c2f	1	2018-11-06

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1302-0	50090130200	7 TABLET, FILM COATED in 1 BOTTLE (50090-1302-0)	2014-11-28	0000-00-00	No	No	Current
50090-1302-1	50090130201	12 TABLET, FILM COATED in 1 BOTTLE (50090-1302-1)	2014-11-28	0000-00-00	No	No	Current
50090-1302-2	50090130202	14 TABLET, FILM COATED in 1 BOTTLE (50090-1302-2)	2014-11-28	0000-00-00	No	No	Current
50090-1302-3	50090130203	16 TABLET, FILM COATED in 1 BOTTLE (50090-1302-3)	2014-11-28	0000-00-00	No	No	Current
50090-1302-4	50090130204	24 TABLET, FILM COATED in 1 BOTTLE (50090-1302-4)	2014-11-28	0000-00-00	No	No	Current
50090-1302-5	50090130205	5 TABLET, FILM COATED in 1 BOTTLE (50090-1302-5)	2014-11-28	0000-00-00	No	No	Current
50090-1302-6	50090130206	10 TABLET, FILM COATED in 1 BOTTLE (50090-1302-6)	2014-11-28	0000-00-00	No	No	Current
50090-1302-7	50090130207	100 TABLET, FILM COATED in 1 BOTTLE (50090-1302-7)	2014-11-28	0000-00-00	No	No	Current
50090-1302-8	50090130208	20 TABLET, FILM COATED in 1 BOTTLE (50090-1302-8)	2017-09-29	0000-00-00	No	No	Current
50090-1302-9	50090130209	30 TABLET, FILM COATED in 1 BOTTLE (50090-1302-9)	2017-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone and Proguanil Hydrochloride	A-S Medication Solutions	2023-03-27	HUMAN PRESCRIPTION DRUG LABEL	25