Atovaquone

Product NDC: 0121-1796
11-digit product format: 001211796
Labeler code: 0121
Product ID: 0121-1796_0d67fa4c-b36a-4d81-8e7d-a661db92df22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atovaquone
Dosage form: SUSPENSION
Route: ORAL
Labeler: PAI Holdings, LLC
Application: ANDA210692
Marketing category: ANDA
Marketing start: 2018-10-11
Marketing end: 0000-00-00
Substance: ATOVAQUONE
Active strength: 1500 mg/10mL
Pharmacologic classes: Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0121-1796		D	Discontinued by firm		2026-08-17
excluded package	package	0121-1796	0121-1796-20	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-1796-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0121-1796-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0121-1796-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0121-1796-20	`367a005e9d99…`	`383a685ebd0f…`

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
A210692-001	ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB		2018-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210692-001	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	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210692-001	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	2018-10-11	`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	A210692-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210692-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210692-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210692-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210692-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210692-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210692-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210692-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210692-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210692-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210692-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210692-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210692-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210692-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210692-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210692-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210692-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210692-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210692-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210692-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210692-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210692-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210692-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210692-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210692-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210692-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210692-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210692-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210692-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210692-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210692-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210692-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210692-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210692-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210692-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210692-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210692-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210692-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210692-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210692-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1796-10	ML - Milliliter	0121-1796	6ada6e6c-f5f2-46d7-b9a8-a2350b7950b6	1	2022-02-07
0121-1796-20	ML - Milliliter	0121-1796	0527d583-c862-4c4d-bdfe-4238d2b56b06	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1796	ATOVAQUONE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]	11	Legacy NDC	20250109_ba4bea2e-aeec-084d-e053-2a95a90a04d4.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atovaquone	ATOVAQUONE	Camber Pharmaceuticals, Inc.	2445304e-4b4e-4358-b098-31f3c49c52ef	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210692 application number: ANDA210692
Atovaquone	ATOVAQUONE	American Health Packaging	1a8a43a2-bc26-4ee5-aa35-22a5477a7129	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210692 application number: ANDA210692
Atovaquone	ATOVAQUONE	ATLANTIC BIOLOGICALS CORP.	40331de7-819e-5965-e063-6294a90ac91d	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210692 application number: ANDA210692
Atovaquone	ATOVAQUONE	ATLANTIC BIOLOGICALS CORP.	f99a8a0c-2b42-4da0-8f5a-e963fc619e8b	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210692 application number: ANDA210692
Atovaquone	ATOVAQUONE	Lohxa	ba3cad0d-cce9-424f-ba5c-557dba8bef12	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210692 application number: ANDA210692
Atovaquone	ATOVAQUONE	NorthStar RxLLC	fc7bdd97-f780-4eed-80e0-72e70267b21a	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210692 application number: ANDA210692
ATOVAQUONE	ATOVAQUONE	Lupin Pharmaceuticals, Inc.	03ddcc33-729c-4d46-ae6b-2ee47978ba16	2021-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210692 application number: ANDA210692

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	Marketing end	Sample	Exclude flag	Status
0121-1796-20	00121179620	2 TRAY in 1 CASE (0121-1796-20) > 10 PACKAGE in 1 TRAY > 10 mL in 1 PACKAGE (0121-1796-10)	2 tray	2021-12-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	11