Lamotrigine

Product NDC: 27241-186
11-digit product format: 272410186
Labeler code: 27241
Product ID: 27241-186_9791ac5c-7be4-4ff8-8de3-21ab21346ca9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Ajanta Pharma USA Inc.
Application: ANDA213271
Marketing category: ANDA
Marketing start: 2021-01-19
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: 2026-12-31
Current FDA listing: Yes

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
A213271-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19
A213271-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19
A213271-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19
A213271-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213271-001	AB
A213271-002	AB
A213271-003	AB
A213271-004	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 4 · 140 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	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A213271-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213271-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213271-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

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 · 4 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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9dfb5f87-0150-4c26-a89f-34f1ab389500	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27241-186-30	Lamotrigine	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-186	LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [AJANTA PHARMA USA INC.]	8	Current NDC, Legacy NDC, 1 package rows	20250306_9dfb5f87-0150-4c26-a89f-34f1ab389500.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	Ajanta Pharma USA Inc.	9dfb5f87-0150-4c26-a89f-34f1ab389500	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213271 application number: ANDA213271 ndc (product): 27241-186

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
103968	lamoTRIgine 100 MG Disintegrating Oral Tablet	PSN	9dfb5f87-0150-4c26-a89f-34f1ab389500	10
252479	lamoTRIgine 200 MG Disintegrating Oral Tablet	PSN	9dfb5f87-0150-4c26-a89f-34f1ab389500	10
198430	lamoTRIgine 25 MG Disintegrating Oral Tablet	PSN	9dfb5f87-0150-4c26-a89f-34f1ab389500	10
252478	lamoTRIgine 50 MG Disintegrating Oral Tablet	PSN	9dfb5f87-0150-4c26-a89f-34f1ab389500	10
103968	lamotrigine 100 MG Disintegrating Oral Tablet	SCD	9dfb5f87-0150-4c26-a89f-34f1ab389500	10
252479	lamotrigine 200 MG Disintegrating Oral Tablet	SCD	9dfb5f87-0150-4c26-a89f-34f1ab389500	10
198430	lamotrigine 25 MG Disintegrating Oral Tablet	SCD	9dfb5f87-0150-4c26-a89f-34f1ab389500	10
252478	lamotrigine 50 MG Disintegrating Oral Tablet	SCD	9dfb5f87-0150-4c26-a89f-34f1ab389500	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-186-30	27241018630	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-186-30)	2021-01-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan	2025-11-26	Human Prescription Drug Label	10