Lamotrigine

Product NDC: 65862-362
11-digit product format: 658620362
Labeler code: 65862
Product ID: 65862-362_743955c4-0ece-4619-8e3e-a9e0a51e9491
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090401
Marketing category: ANDA
Marketing start: 2009-11-04
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: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090401-002	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-11-04
A090401-003	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090401-002	AB
A090401-003	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 3 · 82 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	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090401-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090401-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090401-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090401-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-11-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090401-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090401-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090401-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090401-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090401-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090401-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090401-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090401-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090401-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090401-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090401-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090401-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090401-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090401-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090401-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090401-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090401-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090401-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090401-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090401-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090401-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090401-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090401-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090401-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090401-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090401-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090401-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090401-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090401-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090401-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090401-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090401-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090401-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090401-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090401-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090401-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090401-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090401-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090401-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090401-003	AB	1	`782e0a99824c…`

Additional Listing Data#

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

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 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311264	Internal RxNorm lookup
311265	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
e08920c2-04a3-4fb5-acc5-0af3140f82e9	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	SPL version
65862-362-01	Lamotrigine	100 in 1 BOTTLE	TABLET, CHEWABLE	100	28
65862-362-05	Lamotrigine	500 in 1 BOTTLE	TABLET, CHEWABLE	500	28
65862-362-10	Lamotrigine	10 in 1 CARTON	TABLET, CHEWABLE	10	28
65862-362-10	Lamotrigine	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	28
65862-362-81	Lamotrigine	8000 in 1 BOTTLE	TABLET, CHEWABLE	8000	28
65862-362-99	Lamotrigine	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-362-01	EA - Each	65862-362	542c909c-4aef-41b5-851a-a16c0c201e1b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	15
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	15
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	15
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	15
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	15
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-362	LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED]	25	Current NDC, Legacy NDC, 6 package rows	20231218_e08920c2-04a3-4fb5-acc5-0af3140f82e9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Rising Pharma Holdings, Inc.	f54690b3-bcbb-4d94-95b9-b7591af00117	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090401 application number: ANDA090401
Lamotrigine	LAMOTRIGINE	Aurobindo Pharma Limited	e08920c2-04a3-4fb5-acc5-0af3140f82e9	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090401 application number: ANDA090401 ndc (product): 65862-362

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
311264	lamoTRIgine 25 MG Tablet for Oral Suspension	PSN	e08920c2-04a3-4fb5-acc5-0af3140f82e9	28
311265	lamoTRIgine 5 MG Tablet for Oral Suspension	PSN	e08920c2-04a3-4fb5-acc5-0af3140f82e9	28
311264	lamotrigine 25 MG Tablet for Oral Suspension	SCD	e08920c2-04a3-4fb5-acc5-0af3140f82e9	28
311265	lamotrigine 5 MG Tablet for Oral Suspension	SCD	e08920c2-04a3-4fb5-acc5-0af3140f82e9	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-362-01	65862036201	100 TABLET, CHEWABLE in 1 BOTTLE (65862-362-01)		2009-11-04	0000-00-00	No	No	Current
65862-362-05	65862036205	500 TABLET, CHEWABLE in 1 BOTTLE (65862-362-05)		2009-11-04	0000-00-00	No	No	Current
65862-362-10	65862036210	10 BLISTER PACK in 1 CARTON (65862-362-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK	10 blister pack	2009-11-04	0000-00-00	No	No	Current
65862-362-81	65862036281	8000 TABLET, CHEWABLE in 1 BOTTLE (65862-362-81)		2009-11-04	0000-00-00	No	No	Current
65862-362-99	65862036299	1000 TABLET, CHEWABLE in 1 BOTTLE (65862-362-99)		2009-11-04	0000-00-00	No	No	Current