Lamotrigine

Product NDC: 51672-4140
11-digit product format: 516724140
Labeler code: 51672
Product ID: 51672-4140_e0e7173f-2cec-40a9-8f0a-1bab3e4c910d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA079204
Marketing category: ANDA
Marketing start: 2009-02-04
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 25 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51672-4140		D	Discontinued by firm	2026-10-05
excluded package	package	51672-4140	51672-4140-0	D	Discontinued by firm	2026-10-05
excluded package	package	51672-4140	51672-4140-1	D	Discontinued by firm	2026-10-05
excluded package	package	51672-4140	51672-4140-3	D	Discontinued by firm	2026-10-05
excluded package	package	51672-4140	51672-4140-6	D	Discontinued by firm	2026-10-05

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 · 70 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	51672-4140-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-4140-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-4140-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-4140-1	`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	51672-4140-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-4140-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-4140-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-4140-1	`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	51672-4140-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51672-4140-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51672-4140-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51672-4140-1	`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	51672-4140-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51672-4140-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51672-4140-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51672-4140-1	`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	51672-4140-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51672-4140-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51672-4140-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51672-4140-1	`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	51672-4140-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51672-4140-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51672-4140-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51672-4140-1	`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	51672-4140-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51672-4140-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51672-4140-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51672-4140-1	`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	51672-4140-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51672-4140-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51672-4140-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51672-4140-1	`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	51672-4140-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51672-4140-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51672-4140-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51672-4140-1	`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	51672-4140-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51672-4140-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51672-4140-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51672-4140-1	`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	51672-4140-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51672-4140-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51672-4140-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51672-4140-1	`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	51672-4140-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51672-4140-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51672-4140-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51672-4140-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079204-001	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL			2009-02-04
A079204-002	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL			2009-02-04

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 3 · 86 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	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL		2009-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL		2009-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL		2009-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL		2009-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL		2009-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL		2009-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL		2009-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL		2009-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079204-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079204-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079204-001	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-02-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079204-002	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-02-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A079204-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079204-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079204-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079204-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079204-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079204-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079204-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079204-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079204-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079204-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079204-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079204-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079204-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079204-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079204-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079204-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079204-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079204-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079204-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079204-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079204-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079204-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079204-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079204-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079204-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079204-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079204-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079204-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079204-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079204-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079204-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079204-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079204-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079204-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079204-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079204-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079204-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079204-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079204-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079204-002	AB	1	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
51672-4140-0	2021-12-08	These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994
51672-4140-1	2021-12-08	These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994
51672-4140-3	2021-12-08	These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994
51672-4140-6	2021-12-08	These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994
51672-4140-0	2020-01-31	These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994
51672-4140-1	2020-01-31	These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994
51672-4140-3	2020-01-31	These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994
51672-4140-6	2020-01-31	These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4140-1	EA - Each	51672-4140	6cca7da6-50b7-434b-b7dd-49dce9493174	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lamotrigine	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC.]	9
Lamotrigine	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC.]	9
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LAMOTRIGINE TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC.]	9
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	LAMOTRIGINE TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC.]	9

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3H27498KS	LAMOTRIGINE	84057-84-1	LAMOTRIGINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4140-0	51672414000	10 BLISTER PACK in 1 CARTON (51672-4140-0) > 10 TABLET, CHEWABLE in 1 BLISTER PACK	10 blister pack	2009-02-04	0000-00-00	No	No	Current
51672-4140-1	51672414001	100 TABLET, CHEWABLE in 1 BOTTLE (51672-4140-1)		2009-02-04	0000-00-00	No	No	Current
51672-4140-3	51672414003	1000 TABLET, CHEWABLE in 1 BOTTLE (51672-4140-3)		2009-02-04	0000-00-00	No	No	Current
51672-4140-6	51672414006	30 TABLET, CHEWABLE in 1 BOTTLE (51672-4140-6)		2009-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries Ltd.	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	10