Atovaquone

Product NDC: 69452-252
11-digit product format: 694520252
Labeler code: 69452
Product ID: 69452-252_4523911f-9d9c-4b0c-e063-6394a90ac76d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atovaquone
Dosage form: SUSPENSION
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA212918
Marketing category: ANDA
Marketing start: 2021-06-01
Substance: ATOVAQUONE
Active strength: 750 mg/5mL
Pharmacologic classes: Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A212918-001	ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB		2021-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212918-001	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.

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	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212918-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2021-03-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212918-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212918-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212918-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212918-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212918-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212918-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212918-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212918-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212918-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212918-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212918-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212918-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212918-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212918-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212918-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212918-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212918-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212918-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212918-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212918-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212918-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212918-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212918-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212918-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212918-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212918-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212918-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212918-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212918-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212918-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212918-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212918-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212918-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212918-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212918-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Atovaquone
Listing expiration: 2026-12-31

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
bff4f4fc-6307-f414-e053-2a95a90ac0de	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69452-252-87	Atovaquone	210 mL in 1 BOTTLE	SUSPENSION	210		5
69452-252-87	Atovaquone	1 in 1 CARTON	SUSPENSION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-252-87	ML - Milliliter	69452-252	c5fa876d-5048-4044-9f60-69c4e658e35f	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-252	ATOVAQUONE SUSPENSION [BIONPHARMA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20231226_bff4f4fc-6307-f414-e053-2a95a90ac0de.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	ATOVAQUONE	Golden State Medical Supply, Inc.	ddbfe1a9-df9b-79b0-e053-2995a90acc9b	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212918 application number: ANDA212918
Atovaquone	ATOVAQUONE	Bionpharma Inc.	bff4f4fc-6307-f414-e053-2a95a90ac0de	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212918 application number: ANDA212918 ndc (product): 69452-252
Atovaquone	ATOVAQUONE	Kesin Pharma	16b69156-e5de-c601-e063-6394a90afeae	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212918 application number: ANDA212918
Atovaquone	ATOVAQUONE	A2A Integrated Pharmaceuticals, LLC	27d64592-5078-6122-e063-6394a90ae074	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212918 application number: ANDA212918

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	16b69156-e5de-c601-e063-6394a90afeae	5
308429	atovaquone 750 MG in 5 mL Oral Suspension	PSN	bff4f4fc-6307-f414-e053-2a95a90ac0de	5
308429	atovaquone 150 MG/ML Oral Suspension	SCD	16b69156-e5de-c601-e063-6394a90afeae	5
308429	atovaquone 150 MG/ML Oral Suspension	SCD	bff4f4fc-6307-f414-e053-2a95a90ac0de	5
308429	atovaquone 1500 MG per 10 ML Oral Suspension	SY	16b69156-e5de-c601-e063-6394a90afeae	5
308429	atovaquone 1500 MG per 10 ML Oral Suspension	SY	bff4f4fc-6307-f414-e053-2a95a90ac0de	5
308429	atovaquone 750 MG per 5 ML Oral Suspension	SY	16b69156-e5de-c601-e063-6394a90afeae	5
308429	atovaquone 750 MG per 5 ML Oral Suspension	SY	bff4f4fc-6307-f414-e053-2a95a90ac0de	5
308429	atovaquone 750 MG in 5 mL Oral Suspension	PSN	ddbfe1a9-df9b-79b0-e053-2995a90acc9b	4
308429	atovaquone 150 MG/ML Oral Suspension	SCD	ddbfe1a9-df9b-79b0-e053-2995a90acc9b	4
308429	atovaquone 1500 MG per 10 ML Oral Suspension	SY	ddbfe1a9-df9b-79b0-e053-2995a90acc9b	4
308429	atovaquone 750 MG per 5 ML Oral Suspension	SY	ddbfe1a9-df9b-79b0-e053-2995a90acc9b	4
308429	atovaquone 750 MG in 5 mL Oral Suspension	PSN	27d64592-5078-6122-e063-6394a90ae074	2
308429	atovaquone 150 MG/ML Oral Suspension	SCD	27d64592-5078-6122-e063-6394a90ae074	2
308429	atovaquone 1500 MG per 10 ML Oral Suspension	SY	27d64592-5078-6122-e063-6394a90ae074	2
308429	atovaquone 750 MG per 5 ML Oral Suspension	SY	27d64592-5078-6122-e063-6394a90ae074	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-252-87	69452025287	1 BOTTLE in 1 CARTON (69452-252-87) / 210 mL in 1 BOTTLE	1 bottle	2021-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone	Golden State Medical Supply, Inc.	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	4
Atovaquone	Bionpharma Inc. \| CoreRx Inc.	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	5
Atovaquone	Kesin Pharma	2025-09-15	HUMAN PRESCRIPTION DRUG LABEL	5
Atovaquone	A2A Integrated Pharmaceuticals, LLC	2025-01-02	HUMAN PRESCRIPTION DRUG LABEL	2