Lamotrigine

Product NDC: 68462-229
Requested package NDC: 68462-229-10
11-digit product format: 684620229
Labeler code: 68462
Product ID: 68462-229_fc701d94-bfc5-44c4-8667-6414ee7226ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA079099
Marketing category: ANDA
Marketing start: 2009-02-19
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 43.

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
A079099-001	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-02-19
A079099-002	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079099-001	AB
A079099-002	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 · 86 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	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079099-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079099-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-02-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079099-001	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079099-002	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-02-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A079099-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079099-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079099-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079099-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079099-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079099-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079099-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079099-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079099-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079099-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079099-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079099-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079099-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079099-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079099-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079099-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079099-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079099-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079099-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079099-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079099-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079099-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079099-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079099-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079099-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079099-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079099-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079099-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079099-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079099-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079099-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079099-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079099-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079099-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079099-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079099-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079099-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079099-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079099-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079099-002	AB	1	`74a2ff9319b5…`

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	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
50fcf452-2d21-493e-a1dd-0c6ea9ac6184	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
68462-229-01	Lamotrigine	100 in 1 BOTTLE	TABLET, CHEWABLE	100	26
68462-229-10	Lamotrigine	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000	26
68462-229-90	Lamotrigine	90 in 1 BOTTLE	TABLET, CHEWABLE	90	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-229-01	EA - Each	68462-229	c98a95bd-223b-4fb0-b123-1024a569404f	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 [GLENMARK PHARMACEUTICALS INC., USA]	15
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA]	15
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA]	15
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA]	15
SODIUM STARCH GLYCOLATE TYPE B POTATO	INACTIVE INGREDIENT	27NA468985	LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-229	LAMOTRIGINE TABLET, CHEWABLE [GLENMARK PHARMACEUTICALS INC., USA]	24	Current NDC, Legacy NDC, 3 package rows	20240621_50fcf452-2d21-493e-a1dd-0c6ea9ac6184.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	Glenmark Pharmaceuticals Inc., USA	50fcf452-2d21-493e-a1dd-0c6ea9ac6184	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079099 application number: ANDA079099 ndc (package): 68462-229-10 ndc (product): 68462-229 ndc11 (package): 68462022910

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	50fcf452-2d21-493e-a1dd-0c6ea9ac6184	26
311265	lamoTRIgine 5 MG Tablet for Oral Suspension	PSN	50fcf452-2d21-493e-a1dd-0c6ea9ac6184	26
311264	lamotrigine 25 MG Tablet for Oral Suspension	SCD	50fcf452-2d21-493e-a1dd-0c6ea9ac6184	26
311265	lamotrigine 5 MG Tablet for Oral Suspension	SCD	50fcf452-2d21-493e-a1dd-0c6ea9ac6184	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-229-10	68462022910	1000 TABLET, CHEWABLE in 1 BOTTLE (68462-229-10)	2009-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	26