ethosuximide

Product NDC: 68382-443
11-digit product format: 683820443
Labeler code: 68382
Product ID: 68382-443_f4d37571-27b3-4d2b-a211-c21491d75718
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ethosuximide
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA200892
Marketing category: ANDA
Marketing start: 2012-10-10
Marketing end: 0000-00-00
Substance: ETHOSUXIMIDE
Active strength: 250 1/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-443		I	Inactivated by FDA	2026-08-17
excluded package	package	68382-443	68382-443-01	I	Inactivated by FDA	2026-08-17
excluded package	package	68382-443	68382-443-05	I	Inactivated by FDA	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 2 · 66 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	68382-443-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-443-01	`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	68382-443-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-443-01	`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	68382-443-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-443-01	`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	68382-443-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-443-01	`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	68382-443-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-443-01	`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	68382-443-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-443-01	`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	68382-443-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-443-01	`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	68382-443-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-443-01	`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	68382-443-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-443-01	`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	68382-443-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-443-01	`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	68382-443-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-443-01	`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	68382-443-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68382-443-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68382-443-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68382-443-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68382-443-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68382-443-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68382-443-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68382-443-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68382-443-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68382-443-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68382-443-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68382-443-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68382-443-05	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68382-443-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68382-443-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68382-443-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68382-443-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68382-443-01	`e2bbac7714bc…`	`27bdfed8d636…`

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
A200892-001	ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE / ORAL			2012-09-25

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	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL		2012-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200892-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200892-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200892-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200892-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200892-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200892-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200892-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200892-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200892-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200892-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200892-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200892-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200892-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200892-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200892-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200892-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200892-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200892-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200892-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200892-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200892-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200892-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200892-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200892-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200892-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200892-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200892-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200892-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200892-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200892-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200892-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200892-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200892-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200892-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200892-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200892-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200892-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200892-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200892-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200892-001	BX	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dcc989c7-4ccb-d599-44b3-233abc5285bb	Product name	3	20200708

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68382-443-01	2019-11-13	C162847	48780-1	97449f38-cccb-f6ea-e053-dbdaa90aa703	Ethosuximide Capsules,USP
68382-443-05	2019-11-13	C162847	48780-1	97449f38-cccb-f6ea-e053-dbdaa90aa703	Ethosuximide Capsules,USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68382-443-01	ethosuximide	100 in 1 BOTTLE	CAPSULE	100		1
68382-443-05	ethosuximide	500 in 1 BOTTLE	CAPSULE	500		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHOSUXIMIDE	ACTIVE INGREDIENT	5SEH9X1D1D	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
ETHOSUXIMIDE	ACTIVE MOIETY	5SEH9X1D1D	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-443	ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	1	Legacy NDC, 2 package rows	20121010_cb5577e2-e906-438f-b13d-e55709a0e7fd.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
ETHOSUXIMIDE	ETHOSUXIMIDE	Chartwell RX, LLC	43fdfd16-c723-452a-9c1d-accf6f7c622e	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200892 application number: ANDA200892

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197682	ethosuximide 250 MG Oral Capsule	PSN	cb5577e2-e906-438f-b13d-e55709a0e7fd	1
197682	ethosuximide 250 MG Oral Capsule	SCD	cb5577e2-e906-438f-b13d-e55709a0e7fd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68382-443-01	68382044301	100 in 1 BOTTLE	Historical
68382-443-05	68382044305	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ethosuximide Capsules,USP	Zydus Pharmaceuticals (USA) Inc. \| Emcure Pharmaceuticals USA Inc.	2012-05-30	HUMAN PRESCRIPTION DRUG LABEL	1