Lamotrigine

Product NDC: 49884-487
11-digit product format: 498840487
Labeler code: 49884
Product ID: 49884-487_983458ba-0e97-42af-952c-3662407dde00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA204158
Marketing category: ANDA
Marketing start: 2015-12-16
Substance: LAMOTRIGINE
Active strength: 200 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 package	package	49884-487	49884-487-41	D	Discontinued by firm		2026-10-05
excluded package	package	49884-487	49884-487-77	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 1 · 18 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	49884-487-77	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49884-487-41	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	49884-487-77	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49884-487-41	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	49884-487-77	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49884-487-41	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	49884-487-77	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49884-487-41	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	49884-487-77	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49884-487-41	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	49884-487-77	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49884-487-41	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	49884-487-77	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49884-487-41	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	49884-487-77	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49884-487-41	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	49884-487-77	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49884-487-41	`0efc9e666f02…`	`f202fb6c5f17…`

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	TE codes	Approval date
A204158-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27
A204158-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27
A204158-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27
A204158-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204158-001	AB
A204158-002	AB
A204158-003	AB
A204158-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204158-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204158-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204158-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204158-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-10-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204158-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204158-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204158-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204158-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204158-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204158-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204158-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204158-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204158-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204158-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204158-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204158-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204158-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204158-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204158-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204158-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204158-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204158-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204158-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204158-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204158-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204158-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204158-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204158-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204158-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204158-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204158-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204158-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204158-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204158-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204158-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204158-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204158-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204158-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204158-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204158-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204158-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204158-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204158-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204158-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lamotrigine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMOTRIGINE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3H27498KS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103968	Internal RxNorm lookup
198430	Internal RxNorm lookup
252478	Internal RxNorm lookup
252479	Internal RxNorm lookup
851748	Internal RxNorm lookup
851750	Internal RxNorm lookup
851752	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
003663e5-c0c7-4fc1-a64d-313f2a5b10d2	Available on FDA.report

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49884-487-11	Lamotrigine	30 in 1 DOSE PACK	TABLET, ORALLY DISINTEGRATING	30	45
49884-487-41	Lamotrigine	14 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	14	45
49884-487-77	Lamotrigine	16 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	16	45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-487-11	EA - Each	49884-487	ef19cdac-a42a-48a4-87dd-fbf090d2a588	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lamotrigine	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
Lamotrigine	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	LAMOTRIGINE (LAMOTRIGINE ) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-487	LAMOTRIGINE TABLET, ORALLY DISINTEGRATING LAMOTRIGINE KIT [ENDO USA, INC.]	40	Current NDC, Legacy NDC, 3 package rows	20241212_003663e5-c0c7-4fc1-a64d-313f2a5b10d2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Par Health USA, LLC	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204158 application number: ANDA204158 ndc (product): 49884-487

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
851752	{14 (lamotrigine 100 MG Disintegrating Oral Tablet) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack	GPCK	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
851748	{21 (lamotrigine 25 MG Disintegrating Oral Tablet) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack	GPCK	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
851750	{7 (lamotrigine 100 MG Disintegrating Oral Tablet) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack	GPCK	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
103968	lamoTRIgine 100 MG Disintegrating Oral Tablet	PSN	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
252479	lamoTRIgine 200 MG Disintegrating Oral Tablet	PSN	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
851750	lamoTRIgine 25 MG (14), 50 MG (14), 100 MG (7) Disintegrating Oral Tablet 35 Count Pack	PSN	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
851748	lamoTRIgine 25 MG (21), 50 MG (7) Disintegrating Oral Tablet 28 Count Pack	PSN	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
198430	lamoTRIgine 25 MG Disintegrating Oral Tablet	PSN	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
851752	lamoTRIgine 50 MG (42), 100 MG (14) Disintegrating Oral Tablet 56 Count Pack	PSN	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
252478	lamoTRIgine 50 MG Disintegrating Oral Tablet	PSN	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
103968	lamotrigine 100 MG Disintegrating Oral Tablet	SCD	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
252479	lamotrigine 200 MG Disintegrating Oral Tablet	SCD	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
198430	lamotrigine 25 MG Disintegrating Oral Tablet	SCD	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45
252478	lamotrigine 50 MG Disintegrating Oral Tablet	SCD	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	45

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-487-11	49884048711	30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-487-11)	2015-12-16	0000-00-00	No	No	Current
49884-487-41	49884048741	14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-487-41)	2015-12-16	0000-00-00	No	No	Current
49884-487-77	49884048777	16 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-487-77)	2015-12-16	0000-00-00	No	No	Current