ATOVAQUONE

Product NDC: 65162-693
11-digit product format: 651620693
Labeler code: 65162
Product ID: 65162-693_ea283214-c6a9-42be-a5fe-b35a74aa56af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATOVAQUONE
Dosage form: SUSPENSION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA202960
Marketing category: ANDA
Marketing start: 2011-02-09
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 42.

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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A202960-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2014-03-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A202960-001	AB	1	`e64feba35796…`

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
b7398fcf-522a-488a-8dd6-051561f62804	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-693-88	ATOVAQUONE	1 in 1 CARTON	SUSPENSION	1		24
65162-693-88	ATOVAQUONE	210 mL in 1 BOTTLE	SUSPENSION	210		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-693-88	ML - Milliliter	65162-693	cc070f49-aa4a-4bf6-91cf-02a1907221f5	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-693	ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS LLC]	22	Current NDC, Legacy NDC, 2 package rows	20241025_b7398fcf-522a-488a-8dd6-051561f62804.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 · 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
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 ndc (product): 65162-693
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308429	atovaquone 750 MG in 5 mL Oral Suspension	PSN	b7398fcf-522a-488a-8dd6-051561f62804	24
308429	atovaquone 150 MG/ML Oral Suspension	SCD	b7398fcf-522a-488a-8dd6-051561f62804	24
308429	atovaquone 1500 MG per 10 ML Oral Suspension	SY	b7398fcf-522a-488a-8dd6-051561f62804	24
308429	atovaquone 750 MG per 5 ML Oral Suspension	SY	b7398fcf-522a-488a-8dd6-051561f62804	24
308429	atovaquone 750 MG in 5 mL Oral Suspension	PSN	4124ad97-f6b9-8afb-e063-6294a90ab970	1
308429	atovaquone 150 MG/ML Oral Suspension	SCD	4124ad97-f6b9-8afb-e063-6294a90ab970	1
308429	atovaquone 1500 MG per 10 ML Oral Suspension	SY	4124ad97-f6b9-8afb-e063-6294a90ab970	1
308429	atovaquone 750 MG per 5 ML Oral Suspension	SY	4124ad97-f6b9-8afb-e063-6294a90ab970	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-693-88	65162069388	1 BOTTLE in 1 CARTON (65162-693-88) / 210 mL in 1 BOTTLE	1 bottle	2011-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATOVAQUONE	AvKARE	2026-06-14	HUMAN PRESCRIPTION DRUG LABEL	1
ATOVAQUONE	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	24
ATOVAQUONE	AvPAK	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	1
Atovaquone	VistaPharm, LLC	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	10