Lamotrigine

Product NDC: 0615-7545
11-digit product format: 006157545
Labeler code: 0615
Product ID: 0615-7545_6bf9a99a-7d36-4e31-b6b5-5ea65b5e942e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA076388
Marketing category: ANDA
Marketing start: 2008-07-22
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 100 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: 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	0615-7545		D	Discontinued by firm	2026-08-11
excluded package	package	0615-7545	0615-7545-31	D	Discontinued by firm	2026-08-11
excluded package	package	0615-7545	0615-7545-39	D	Discontinued by firm	2026-08-11

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 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7545-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7545-31	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7545-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7545-31	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7545-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7545-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7545-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7545-31	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7545-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7545-31	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7545-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7545-31	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7545-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7545-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7545-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7545-31	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7545-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7545-31	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7545-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7545-31	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7545-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7545-31	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7545-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7545-31	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7545-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7545-31	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7545-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7545-31	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7545-31	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7545-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076388-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30
A076388-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30
A076388-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30
A076388-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076388-001	LAMOTRIGINE	25MG	TABLET / ORAL	2006-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076388-002	LAMOTRIGINE	100MG	TABLET / ORAL	2006-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076388-003	LAMOTRIGINE	150MG	TABLET / ORAL	2006-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076388-004	LAMOTRIGINE	200MG	TABLET / ORAL	2006-08-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076388-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076388-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076388-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076388-004	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A076388-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076388-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076388-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076388-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076388-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076388-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076388-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076388-004	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0615-7545-31	2021-07-07	These highlights do not include all the information needed to use lamotrigine tablets safely and effectively. See full prescribing information for lamotrigine tablets. LAMOTRIGINE tablets for oral use Initial U.S. Approval: 1994
0615-7545-39	2021-07-07	These highlights do not include all the information needed to use lamotrigine tablets safely and effectively. See full prescribing information for lamotrigine tablets. LAMOTRIGINE tablets for oral use Initial U.S. Approval: 1994
0615-7545-31	2020-01-31	These highlights do not include all the information needed to use lamotrigine tablets safely and effectively. See full prescribing information for lamotrigine tablets. LAMOTRIGINE tablets for oral use Initial U.S. Approval: 1994
0615-7545-39	2020-01-31	These highlights do not include all the information needed to use lamotrigine tablets safely and effectively. See full prescribing information for lamotrigine tablets. LAMOTRIGINE tablets for oral use Initial U.S. Approval: 1994

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LAMOTRIGINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine	NCS HealthCare of KY, Inc dba Vangard Labs	2016-01-11	HUMAN PRESCRIPTION DRUG LABEL	3