LAMOTRIGINE

Product NDC: 50436-0149
11-digit product format: 504360149
Labeler code: 50436
Product ID: 50436-0149_35004c15-2ff1-4184-b6cb-4d3ec7af6098
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA077783
Marketing category: ANDA
Marketing start: 2010-11-01
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: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50436-0149		I	Inactivated by FDA		2026-10-02
excluded package	package	50436-0149	50436-0149-1	I	Inactivated by FDA		2026-10-02

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 · 38 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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`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	50436-0149-1	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A077783-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01
A077783-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01
A077783-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01
A077783-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01

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	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`

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	A077783-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077783-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077783-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077783-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-004	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
14a9502b-3d70-0496-a7e1-b16edaa005b8	Product name	5	20250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0	Product name	7	20250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-0149-1	2021-01-29	C162847	48780-1	ba0f9c33-22b5-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use LAMOTRIGINE tablets, USP safely and effectively. See full prescribing information for LAMOTRIGINE tablets, USP. LAMOTRIGINE tablets, USP, for oral use Initial U.S. Approval:1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0149-1	LAMOTRIGINE	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-0149-1	EA - Each	50436-0149	70c71d73-2fdc-46a3-ab71-44062debc48e	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0149	LAMOTRIGINE TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20171011_c578d89a-7ea6-4927-af1a-a39e975d4fa7.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198427	lamoTRIgine 100 MG Oral Tablet	PSN	c578d89a-7ea6-4927-af1a-a39e975d4fa7	2
198427	lamotrigine 100 MG Oral Tablet	SCD	c578d89a-7ea6-4927-af1a-a39e975d4fa7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0149-1	50436014901	30 in 1 BOTTLE	Historical