Lamotrigine

Product NDC: 50090-5828
Requested package NDC: 50090-5828-0
11-digit product format: 500905828
Labeler code: 50090
Product ID: 50090-5828_ce17f544-8282-4f1c-86b0-21193b8b2601
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077633
Marketing category: ANDA
Marketing start: 2009-01-27
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-5828	50090-5828-0	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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077633-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A077633-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27
A077633-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A077633-004	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A077633-005	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27
A077633-006	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077633-001	AB
A077633-003	AB
A077633-004	AB
A077633-005	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 7 · 246 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	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`

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	A077633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077633-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077633-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077633-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077633-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077633-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077633-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077633-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077633-005	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5828-0	2023-01-30	C162847	48780-1	f386c64a-3c8f-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS FOR ORAL SUSPENSION. LAMOTRIGINE tablets, for oral use LAMOTRIGINE tablets for oral suspension Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5828-0	Lamotrigine	1 in 1 BLISTER PACK	TABLET	1		10
50090-5828-0	Lamotrigine	32 in 1 BOX, UNIT-DOSE	TABLET	32		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5828-0	EA - Each	50090-5828	427b5f03-f410-49ac-b559-51a073276b73	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5828	LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]	10	Legacy NDC, 2 package rows	20211106_35418581-1942-44e1-ab92-0653fa5f3336.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 1 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	American Health Packaging	35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	15d801a0-f0a5-40c1-bc88-d5ba9a02c696	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Cardinal Health 107, LLC	20e156df-a2b6-4710-b526-0419cd17dd33	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Major Pharmaceuticals	12e0be85-0961-4fe0-b973-83251ecf0f65	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	American Health Packaging	6034a8b8-9e80-43ca-b84f-ea82f788268c	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals Inc.	634dbe6c-4874-4d54-aa25-be02d3341f16	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Quallent Pharmaceuticals Health LLC	7977c87f-b459-486a-9edc-0a2071c46f4c	2026-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Northwind Health Company, LLC	03fd8413-df56-50ab-e063-6394a90a6950	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Northstar Rx LLC.	aabc64fe-1f17-4140-81f2-7d4506db6c8b	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Cardinal Health 107, LLC	beb24a4f-ab0b-435a-b60b-2b8d565ecd75	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Zydus Pharmaceuticals USA Inc.	e849033b-a3bc-408e-88de-7cd1d2660949	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Zydus Lifesciences Limited	0f2f7421-56d4-45d0-9d2d-dc1edaede039	2025-10-04		Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	2cf33586-e48a-4b4e-b14b-33de2be63c1d	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	4bbc140c-6092-416d-865d-49b89c5ecdd0	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	cf03f130-067f-401c-8501-0d78a989a319	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	NuCare Pharmaceuticals,Inc.	065e97c9-3c5f-16e6-e063-6294a90a13fc	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	NCS HealthCare of KY, LLC dba Vangard Labs	e243e803-e95f-47a6-a6da-5fed657f4462	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	5a9575bb-230e-46ae-b58e-41554bad45eb	2023-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633

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	35418581-1942-44e1-ab92-0653fa5f3336	10
198427	lamotrigine 100 MG Oral Tablet	SCD	35418581-1942-44e1-ab92-0653fa5f3336	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5828-0	50090582800	32 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5828-0) > 1 TABLET in 1 BLISTER PACK	32 blister pack	2021-10-26	0000-00-00	No	No	Current