Lamotrigine

Product NDC: 53002-2512
11-digit product format: 530022512
Labeler code: 53002
Product ID: 53002-2512_5b186321-b12a-4762-9997-2860478eb923
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA090170
Marketing category: ANDA
Marketing start: 2011-11-01
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: 2021-12-31
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	53002-2512		I	Inactivated by FDA	2026-08-03
excluded package	package	53002-2512	53002-2512-0	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-2512	53002-2512-3	I	Inactivated by FDA	2026-08-03

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 · 27 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2512-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2512-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2512-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2512-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2512-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2512-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2512-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2512-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2512-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2512-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2512-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2512-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2512-0	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2512-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2512-0	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2512-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2512-0	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2512-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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	TE codes	Approval date
A090170-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06
A090170-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06
A090170-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06
A090170-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090170-001	AB
A090170-002	AB
A090170-003	AB
A090170-004	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-004	AB	1	`d06236e962d9…`

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, Related label table
NDC	Effective	Related label
53002-2512-0	2025-01-30	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
53002-2512-3	2025-01-30	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
53002-2512-0	2023-06-08	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
53002-2512-3	2023-06-08	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
53002-2512-0	2023-01-30	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
53002-2512-3	2023-01-30	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-2512-0	Lamotrigine	100 in 1 BOTTLE	TABLET	100		3
53002-2512-3	Lamotrigine	30 in 1 BOTTLE	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2512	LAMOTRIGINE TABLET [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 2 package rows	20230609_610e58a0-81b2-4a44-9882-81bdcd690dca.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	d1691a60-ff0a-4755-b445-1d78309d5af0	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	346f8af3-b850-48e4-bd6e-82ecafca86d2	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	f5761818-4eaf-4335-a77a-9cd703278ded	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	1b5646a9-4724-44b8-8cd0-9c14f5e87f86	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Coupler LLC	55f41c7e-03a6-b84c-e063-6294a90a7d82	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	3ed4590d-71e3-4208-b6c0-98330acc7b85	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Coupler LLC	545fcc0e-1e2b-bdcb-e063-6294a90a4ac7	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	b1601109-5c17-4482-9257-1e0be7546e8f	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Coupler LLC	52b8be5c-ef88-dfa7-e063-6394a90a0500	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Unichem Pharmaceuticals (USA), Inc.	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals, Inc.	16323699-9bf8-43c7-b3aa-589156377872	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals Inc.	09a0d30d-9b8f-4c76-8cdb-8492386b2254	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	6139a858-700c-4eb9-9f84-99d280bde326	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	PD-Rx Pharmaceuticals, Inc.	dc6e6735-d49a-44d8-936d-7c33437bc59e	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	811188be-d231-4b58-8d7a-b01b236fab51	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Northwind Health Company, LLC	db5f7ee5-9bd9-1819-e053-2a95a90a91df	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	84277e2c-370c-4510-92bc-ef33a4a0f508	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	8e1e4fa8-881c-4618-88f6-018ab15db44d	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	53774022-ea0c-42a9-a720-dc755c77b851	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170

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	610e58a0-81b2-4a44-9882-81bdcd690dca	3
198427	lamotrigine 100 MG Oral Tablet	SCD	610e58a0-81b2-4a44-9882-81bdcd690dca	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2512-0	53002251200	100 TABLET in 1 BOTTLE (53002-2512-0)	100 tablet	2019-01-01	0000-00-00	No	No	Current
53002-2512-3	53002251203	30 TABLET in 1 BOTTLE (53002-2512-3)	30 tablet	2019-01-01	0000-00-00	No	No	Current