Lamotrigine

Product NDC: 65841-689
11-digit product format: 658410689
Labeler code: 65841
Product ID: 65841-689_c4eb074b-9cd4-4bcd-868c-473d9364061c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA078009
Marketing category: ANDA
Marketing start: 2009-01-23
Substance: LAMOTRIGINE
Active strength: 5 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 42.

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
A078009-002	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-01-22
A078009-003	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078009-002	AB
A078009-003	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 · 84 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
2026-08-18 06:07:40	2026-07	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078009-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078009-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078009-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078009-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078009-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078009-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078009-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078009-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078009-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078009-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078009-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078009-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078009-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078009-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078009-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078009-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078009-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078009-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078009-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078009-003	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMOTRIGINE	5 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198427	Internal RxNorm lookup
198428	Internal RxNorm lookup
198429	Internal RxNorm lookup
199322	Internal RxNorm lookup
249329	Internal RxNorm lookup
282401	Internal RxNorm lookup
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
0f2f7421-56d4-45d0-9d2d-dc1edaede039	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
65841-689-01	Lamotrigine	100 in 1 BOTTLE	TABLET, CHEWABLE	100	12
65841-689-05	Lamotrigine	500 in 1 BOTTLE	TABLET, CHEWABLE	500	12
65841-689-16	Lamotrigine	90 in 1 BOTTLE	TABLET, CHEWABLE	90	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
BLACK CURRANT	INACTIVE INGREDIENT	9755T40D11	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-689	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 3 package rows	20241204_0f2f7421-56d4-45d0-9d2d-dc1edaede039.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	Zydus Pharmaceuticals USA Inc.	e849033b-a3bc-408e-88de-7cd1d2660949	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078009 application number: ANDA078009
Lamotrigine	LAMOTRIGINE	Zydus Lifesciences Limited	0f2f7421-56d4-45d0-9d2d-dc1edaede039	2025-10-04		Exact identifier application applno (ANDA): 078009 application number: ANDA078009 ndc (product): 65841-689

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
198427	lamoTRIgine 100 MG Oral Tablet	PSN	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
198428	lamoTRIgine 150 MG Oral Tablet	PSN	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
198429	lamoTRIgine 200 MG Oral Tablet	PSN	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
282401	lamoTRIgine 25 MG Oral Tablet	PSN	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
311264	lamoTRIgine 25 MG Tablet for Oral Suspension	PSN	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
249329	lamoTRIgine 250 MG Oral Tablet	PSN	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
311265	lamoTRIgine 5 MG Tablet for Oral Suspension	PSN	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
199322	lamoTRIgine 50 MG Oral Tablet	PSN	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
198427	lamotrigine 100 MG Oral Tablet	SCD	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
198428	lamotrigine 150 MG Oral Tablet	SCD	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
198429	lamotrigine 200 MG Oral Tablet	SCD	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
282401	lamotrigine 25 MG Oral Tablet	SCD	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
311264	lamotrigine 25 MG Tablet for Oral Suspension	SCD	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
249329	lamotrigine 250 MG Oral Tablet	SCD	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
311265	lamotrigine 5 MG Tablet for Oral Suspension	SCD	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12
199322	lamotrigine 50 MG Oral Tablet	SCD	0f2f7421-56d4-45d0-9d2d-dc1edaede039	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-689-01	65841068901	100 TABLET, CHEWABLE in 1 BOTTLE (65841-689-01)	2009-01-23	0000-00-00	No	No	Current
65841-689-05	65841068905	500 TABLET, CHEWABLE in 1 BOTTLE (65841-689-05)	2009-01-23	0000-00-00	No	No	Current
65841-689-16	65841068916	90 TABLET, CHEWABLE in 1 BOTTLE (65841-689-16)	2009-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE).	Zydus Lifesciences Limited	2025-10-04	HUMAN PRESCRIPTION DRUG LABEL	12