LAMICTAL

Product NDC: 0173-0527
11-digit product format: 001730527
Labeler code: 0173
Product ID: 0173-0527_4492fd3c-e068-4599-8a10-0b26ea2a4f91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lamotrigine
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA020764
Marketing category: NDA
Marketing start: 1998-09-03
Substance: LAMOTRIGINE
Active strength: 25 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: 2026-12-31
Current FDA listing: Yes

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 · 6 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
2025-02-02 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	0173-0527-00	`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	0173-0527-00	`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	0173-0527-00	`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	RLD / RS	Approval date
N020764-001	LAMICTAL CD	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24
N020764-002	LAMICTAL CD	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24
N020764-003	LAMICTAL CD	LAMOTRIGINE	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24
N020764-004	LAMICTAL CD	LAMOTRIGINE	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020764-001	AB
N020764-002	AB
N020764-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020764-001	LAMICTAL CD	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	1998-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020764-002	LAMICTAL CD	25MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	1998-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020764-003	LAMICTAL CD	100MG	TABLET, FOR SUSPENSION / ORAL			1998-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020764-004	LAMICTAL CD	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2000-09-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N020764-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020764-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020764-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020764-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020764-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020764-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020764-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020764-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020764-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020764-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020764-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020764-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020764-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020764-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020764-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020764-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020764-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020764-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020764-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020764-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020764-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020764-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020764-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020764-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020764-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020764-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020764-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020764-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020764-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020764-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020764-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020764-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020764-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020764-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020764-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020764-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020764-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020764-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020764-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020764-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: LAMICTAL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMOTRIGINE	25 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 2 · 34 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103968	Internal RxNorm lookup
105018	Internal RxNorm lookup
105019	Internal RxNorm lookup
108782	Internal RxNorm lookup
198427	Internal RxNorm lookup
198428	Internal RxNorm lookup
198429	Internal RxNorm lookup
198430	Internal RxNorm lookup
201239	Internal RxNorm lookup
201240	Internal RxNorm lookup
206201	Internal RxNorm lookup
252478	Internal RxNorm lookup
252479	Internal RxNorm lookup
282401	Internal RxNorm lookup
311264	Internal RxNorm lookup
311265	Internal RxNorm lookup
349010	Internal RxNorm lookup
542426	Internal RxNorm lookup
751139	Internal RxNorm lookup
751563	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
d7e3572d-56fe-4727-2bb4-013ccca22678	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
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-02-01	These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral use LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
2025-02-01	These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral use LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
2025-01-30	These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral use LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
2025-01-30	These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral use LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating 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
0173-0527-00	LAMICTAL	100 in 1 BOTTLE	TABLET, FOR SUSPENSION	100		44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0527-00	EA - Each	0173-0527	0d0af38d-a13f-4511-93dd-cde39e81c463	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
ETHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	47MLB0F1MV	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, CHEWABLE LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0527	LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, FOR SUSPENSION LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]	43	Current NDC, Legacy NDC, 1 package rows	20250507_d7e3572d-56fe-4727-2bb4-013ccca22678.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
LAMICTAL	LAMOTRIGINE	GlaxoSmithKline LLC	d7e3572d-56fe-4727-2bb4-013ccca22678	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020764 application number: NDA020764 ndc (product): 0173-0527

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
851753	{14 (lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal]) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Green Titration Kit (for Patients Taking Enzyme-Inducing Drugs and Not Taking Valproate)]	BPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
795778	{14 (lamotrigine 100 MG Oral Tablet [Lamictal]) / 84 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)]	BPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851749	{21 (lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal]) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Blue Patient Titration Kit (for Patients Taking Valproate)]	BPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
795772	{35 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Blue (For Patients Taking Valproate)]	BPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851751	{7 (lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal]) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal]) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Orange Patient Titration Kit (For Patients Not Taking Enzyme-Inducing Drugs or Valproate)]	BPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
795774	{7 (lamotrigine 100 MG Oral Tablet [Lamictal]) / 42 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Orange (For Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)]	BPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851752	{14 (lamotrigine 100 MG Disintegrating Oral Tablet) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack	GPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
753451	{14 (lamotrigine 100 MG Oral Tablet) / 84 (lamotrigine 25 MG Oral Tablet) } Pack	GPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851748	{21 (lamotrigine 25 MG Disintegrating Oral Tablet) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack	GPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
751139	{35 (lamotrigine 25 MG Oral Tablet) } Pack	GPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851750	{7 (lamotrigine 100 MG Disintegrating Oral Tablet) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack	GPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
751563	{7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } Pack	GPCK	d7e3572d-56fe-4727-2bb4-013ccca22678	44
105018	LaMICtal 100 MG Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
206201	LaMICtal 150 MG Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
542426	LaMICtal 2 MG Tablet for Oral Suspension	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
108782	LaMICtal 200 MG Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
105019	LaMICtal 25 MG Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
201240	LaMICtal 25 MG Tablet for Oral Suspension	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
201239	LaMICtal 5 MG Tablet for Oral Suspension	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849049	LaMICtal ODT 100 MG Disintegrating Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849050	LaMICtal ODT 200 MG Disintegrating Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849051	LaMICtal ODT 25 MG Disintegrating Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849052	LaMICtal ODT 50 MG Disintegrating Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851749	LaMICtal ODT Patient Titration Kit Blue 25 MG (21), 50 MG (7) 28 Count	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851753	LaMICtal ODT Patient Titration Kit Green 50 MG (42), 100 MG (14) 56 Count	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851751	LaMICtal ODT Patient Titration Kit Orange 25 MG (14), 50 MG (14), 100 MG (7) 35 Count	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
795772	LaMICtal Starter Kit Blue 25 MG 35 Count	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
795778	LaMICtal Starter Kit Green 25 MG (84), 100 MG (14) 98 Count	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
795774	LaMICtal Starter Kit Orange 25 MG (42), 100 MG (7) 49 Count	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
103968	lamoTRIgine 100 MG Disintegrating Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
198427	lamoTRIgine 100 MG Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
198428	lamoTRIgine 150 MG Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
349010	lamoTRIgine 2 MG Tablet for Oral Suspension	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
252479	lamoTRIgine 200 MG Disintegrating Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
198429	lamoTRIgine 200 MG Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851750	lamoTRIgine 25 MG (14), 50 MG (14), 100 MG (7) Disintegrating Oral Tablet 35 Count Pack	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851748	lamoTRIgine 25 MG (21), 50 MG (7) Disintegrating Oral Tablet 28 Count Pack	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
751563	lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count Pack	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
753451	lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count Pack	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
198430	lamoTRIgine 25 MG Disintegrating Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
282401	lamoTRIgine 25 MG Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
751139	lamoTRIgine 25 MG Oral Tablet 35 Count Pack	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
311264	lamoTRIgine 25 MG Tablet for Oral Suspension	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
311265	lamoTRIgine 5 MG Tablet for Oral Suspension	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
851752	lamoTRIgine 50 MG (42), 100 MG (14) Disintegrating Oral Tablet 56 Count Pack	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
252478	lamoTRIgine 50 MG Disintegrating Oral Tablet	PSN	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849049	lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
105018	lamotrigine 100 MG Oral Tablet [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
206201	lamotrigine 150 MG Oral Tablet [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
542426	lamotrigine 2 MG Tablet for Oral Suspension [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849050	lamotrigine 200 MG Disintegrating Oral Tablet [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
108782	lamotrigine 200 MG Oral Tablet [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849051	lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
105019	lamotrigine 25 MG Oral Tablet [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
201240	lamotrigine 25 MG Tablet for Oral Suspension [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
201239	lamotrigine 5 MG Tablet for Oral Suspension [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849052	lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]	SBD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
103968	lamotrigine 100 MG Disintegrating Oral Tablet	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
198427	lamotrigine 100 MG Oral Tablet	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
198428	lamotrigine 150 MG Oral Tablet	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
349010	lamotrigine 2 MG Tablet for Oral Suspension	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
252479	lamotrigine 200 MG Disintegrating Oral Tablet	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
198429	lamotrigine 200 MG Oral Tablet	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
198430	lamotrigine 25 MG Disintegrating Oral Tablet	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
282401	lamotrigine 25 MG Oral Tablet	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
311264	lamotrigine 25 MG Tablet for Oral Suspension	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
311265	lamotrigine 5 MG Tablet for Oral Suspension	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
252478	lamotrigine 50 MG Disintegrating Oral Tablet	SCD	d7e3572d-56fe-4727-2bb4-013ccca22678	44
105018	Lamictal 100 MG Oral Tablet	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
206201	Lamictal 150 MG Oral Tablet	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
542426	Lamictal 2 MG Tablet for Oral Suspension	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
108782	Lamictal 200 MG Oral Tablet	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
105019	Lamictal 25 MG Oral Tablet	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
795772	Lamictal Blue (For Patients Taking Valproate)	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
542426	Lamictal CD 2 MG Tablet for Oral Suspension	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
201240	Lamictal CD 25 MG Tablet for Oral Suspension	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
201239	Lamictal CD 5 MG Tablet for Oral Suspension	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
795778	Lamictal Green Kit (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849049	Lamictal ODT 100 MG Disintegrating Oral Tablet	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44
849050	Lamictal ODT 200 MG Disintegrating Oral Tablet	SY	d7e3572d-56fe-4727-2bb4-013ccca22678	44

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0527-00	00173052700	100 TABLET, FOR SUSPENSION in 1 BOTTLE (0173-0527-00)	1998-09-03	0000-00-00	No	No	Current