Atovaquone

Product NDC: 66993-062
11-digit product format: 669930062
Labeler code: 66993
Product ID: 66993-062_58b0ae61-aff1-4cec-bf03-eba8b8569a71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atovaquone
Dosage form: SUSPENSION
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA020500
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-03-20
Marketing end: 2020-09-30
Substance: ATOVAQUONE
Active strength: 750 mg/5mL
Pharmacologic classes: Antimalarial [EPC],Antiprotozoal [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66993-062		D	Discontinued by firm	2026-10-15
excluded package	package	66993-062	66993-062-42	D	Discontinued by firm	2026-10-15
excluded package	package	66993-062	66993-062-72	D	Discontinued by firm	2026-10-15

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 · 36 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	66993-062-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66993-062-42	`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	66993-062-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66993-062-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66993-062-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66993-062-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66993-062-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66993-062-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66993-062-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66993-062-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66993-062-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66993-062-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66993-062-72	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66993-062-42	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66993-062-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66993-062-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66993-062-72	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66993-062-42	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66993-062-72	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66993-062-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66993-062-72	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66993-062-42	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66993-062-72	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66993-062-42	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020500-001	MEPRON	ATOVAQUONE	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020500-001	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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020500-001	MEPRON	750MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1995-02-08	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020500-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020500-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020500-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020500-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-062-72	ML - Milliliter	66993-062	b0b26c0c-1572-4d6f-9fcd-5a79c8475516	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATOVAQUONE	ACTIVE INGREDIENT	Y883P1Z2LT	ATOVAQUONE SUSPENSION [PRASCO LABORATORIES]	3
ATOVAQUONE	ACTIVE MOIETY	Y883P1Z2LT	ATOVAQUONE SUSPENSION [PRASCO LABORATORIES]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ATOVAQUONE SUSPENSION [PRASCO LABORATORIES]	3
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ATOVAQUONE SUSPENSION [PRASCO LABORATORIES]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ATOVAQUONE SUSPENSION [PRASCO LABORATORIES]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATOVAQUONE SUSPENSION [PRASCO LABORATORIES]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ATOVAQUONE SUSPENSION [PRASCO LABORATORIES]	3

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
MEPRON	ATOVAQUONE	GlaxoSmithKline LLC	b426b6bf-f07e-4580-97ae-dfca1ddf5b8f	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020500 application number: NDA020500