ATOVAQUONE

Product NDC: 73190-098
11-digit product format: 731900098
Labeler code: 73190
Product ID: 73190-098_54423fee-da61-25dc-e063-6294a90a2552
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATOVAQUONE
Dosage form: SUSPENSION
Route: ORAL
Labeler: AvKARE
Application: ANDA202960
Marketing category: ANDA
Marketing start: 2026-06-14
Substance: ATOVAQUONE
Active strength: 750 mg/5mL
Pharmacologic classes: Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202960-001	ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB		2014-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A202960-001	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 2 · 43 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
2026-09-14 22:38:34	2026-08	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202960-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202960-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202960-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202960-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202960-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202960-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202960-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202960-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202960-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202960-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202960-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202960-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202960-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202960-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202960-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202960-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202960-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202960-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202960-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202960-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202960-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202960-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202960-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202960-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202960-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202960-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202960-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202960-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202960-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202960-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202960-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202960-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202960-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202960-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202960-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202960-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202960-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202960-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202960-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202960-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ATOVAQUONE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATOVAQUONE	750 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Y883P1Z2LT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308429	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
54423fee-da60-25dc-e063-6294a90a2552	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATOVAQUONE	ATOVAQUONE	AvKARE	54423fee-da60-25dc-e063-6294a90a2552	2026-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202960 application number: ANDA202960 ndc (product): 73190-098
ATOVAQUONE	ATOVAQUONE	Amneal Pharmaceuticals LLC	b7398fcf-522a-488a-8dd6-051561f62804	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202960 application number: ANDA202960
ATOVAQUONE	ATOVAQUONE	AvPAK	4124ad97-f6b9-8afb-e063-6294a90ab970	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202960 application number: ANDA202960

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y883P1Z2LT	ATOVAQUONE	95233-18-4	ATOVAQUONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73190-098-21	73190009821	1 BOTTLE in 1 CARTON (73190-098-21) / 210 mL in 1 BOTTLE	1 bottle	2026-06-14	No	No	Current