ethosuximide

Product NDC: 46672-641
11-digit product format: 466720641
Labeler code: 46672
Product ID: 46672-641_a2a426a3-9574-1748-e053-2a95a90a0f62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ethosuximide
Dosage form: SOLUTION
Route: ORAL
Labeler: Mikart, LLC
Application: ANDA040506
Marketing category: ANDA
Marketing start: 2003-12-22
Marketing end: 0000-00-00
Substance: ETHOSUXIMIDE
Active strength: 250 mg/5mL
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040506-001	ETHOSUXIMIDE	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA		2003-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040506-001	AA

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 · 43 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
2026-09-14 22:38:34	2026-08	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA	2003-12-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040506-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040506-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040506-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040506-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040506-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040506-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040506-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040506-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040506-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040506-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040506-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040506-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040506-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040506-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040506-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040506-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040506-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040506-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040506-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040506-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040506-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040506-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040506-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040506-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040506-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040506-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040506-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040506-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040506-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040506-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040506-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040506-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040506-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040506-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040506-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040506-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040506-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040506-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040506-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040506-001	AA	1	`f41ea6bd6efb…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHOSUXIMIDE	ACTIVE INGREDIENT	5SEH9X1D1D	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
ETHOSUXIMIDE	ACTIVE MOIETY	5SEH9X1D1D	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
ETHYL MALTOL	INACTIVE INGREDIENT	L6Q8K29L05	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ETHOSUXIMIDE SOLUTION [MIKART, INC.]	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethosuximide	ETHOSUXIMIDE	Chartwell Governmental & Specialty RX, LLC.	a825265d-ace9-4463-a16d-f6d5e1e31188	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040506 application number: ANDA040506
Ethosuximide	ETHOSUXIMIDE	Chartwell RX, LLC	9812840a-004d-46fa-8414-7d04a384e06a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040506 application number: ANDA040506

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5SEH9X1D1D	ETHOSUXIMIDE	77-67-8	ETHOSUXIMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46672-641-16	46672064116	473 mL in 1 BOTTLE, PLASTIC (46672-641-16)	473 ml	2003-12-22	0000-00-00	No	No	Current