atovaquone

Product NDC: 68462-421
11-digit product format: 684620421
Labeler code: 68462
Product ID: 68462-421_b221c446-0200-4c11-bd0c-ff9ec502bc19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atovaquone
Dosage form: SUSPENSION
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA209685
Marketing category: ANDA
Marketing start: 2017-12-31
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
A209685-001	ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB		2018-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209685-001	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	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209685-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-11-21	`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	A209685-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209685-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209685-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209685-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209685-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209685-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209685-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209685-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209685-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209685-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209685-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209685-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209685-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209685-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209685-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209685-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209685-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209685-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209685-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209685-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209685-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209685-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209685-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209685-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209685-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209685-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209685-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209685-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209685-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209685-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209685-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209685-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209685-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209685-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209685-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209685-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209685-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209685-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209685-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209685-001	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
9045ba6f-938e-4717-bfa2-a3efe52f04cd	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	SPL version
68462-421-21	atovaquone	210 mL in 1 BOTTLE	SUSPENSION	210	9
68462-421-69	atovaquone	42 in 1 CARTON	SUSPENSION	42	9
68462-421-69	atovaquone	5 mL in 1 POUCH	SUSPENSION	5	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-421-21	ML - Milliliter	68462-421	3b018631-cb09-40a0-8d7c-73f9df2bab52	1	2019-01-24
68462-421-69	ML - Milliliter	68462-421	053a752b-9d34-4884-b44d-8e07ebfe342a	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-421	ATOVAQUONE SUSPENSION [GLENMARK PHARMACEUTICALS INC., USA]	8	Current NDC, Legacy NDC, 3 package rows	20240103_9045ba6f-938e-4717-bfa2-a3efe52f04cd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
atovaquone	ATOVAQUONE	Glenmark Pharmaceuticals Inc., USA	9045ba6f-938e-4717-bfa2-a3efe52f04cd	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209685 application number: ANDA209685 ndc (product): 68462-421

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	9045ba6f-938e-4717-bfa2-a3efe52f04cd	9
308429	atovaquone 150 MG/ML Oral Suspension	SCD	9045ba6f-938e-4717-bfa2-a3efe52f04cd	9
308429	atovaquone 1500 MG per 10 ML Oral Suspension	SY	9045ba6f-938e-4717-bfa2-a3efe52f04cd	9
308429	atovaquone 750 MG per 5 ML Oral Suspension	SY	9045ba6f-938e-4717-bfa2-a3efe52f04cd	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-421-21	68462042121	210 mL in 1 BOTTLE (68462-421-21)	210 ml	2017-12-31	0000-00-00	No	No	Current
68462-421-69	68462042169	42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCH	42 pouch	2017-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
atovaquone	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited \| PPL Healthcare LLC	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	9