Lamotrigine

Product NDC: 0781-5124
11-digit product format: 007815124
Labeler code: 0781
Product ID: 0781-5124_b0406e06-b384-4f8a-9c2c-e8dba2389c42
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA078645
Marketing category: ANDA
Marketing start: 2010-01-05
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 150 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-5124		D	Discontinued by firm	2026-10-05
excluded package	package	0781-5124	0781-5124-01	D	Discontinued by firm	2026-10-05
excluded package	package	0781-5124	0781-5124-10	D	Discontinued by firm	2026-10-05
excluded package	package	0781-5124	0781-5124-13	D	Discontinued by firm	2026-10-05
excluded package	package	0781-5124	0781-5124-31	D	Discontinued by firm	2026-10-05
excluded package	package	0781-5124	0781-5124-60	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 · 78 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	0781-5124-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5124-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5124-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5124-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5124-13	`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	0781-5124-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5124-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5124-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5124-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5124-13	`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	0781-5124-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5124-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5124-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5124-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5124-13	`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	0781-5124-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5124-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5124-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5124-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5124-13	`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	0781-5124-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5124-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5124-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5124-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5124-13	`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	0781-5124-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5124-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5124-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5124-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5124-13	`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	0781-5124-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5124-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5124-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5124-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5124-13	`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	0781-5124-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5124-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5124-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5124-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5124-13	`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	0781-5124-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5124-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5124-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5124-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5124-13	`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	0781-5124-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5124-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5124-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5124-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5124-13	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078645-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27
A078645-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27
A078645-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27
A078645-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078645-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078645-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078645-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078645-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMOTRIGINE TABLET LAMOTRIGINE KIT [SANDOZ INC]	4