lamotrigine

Product NDC: 46708-095
11-digit product format: 467080095
Labeler code: 46708
Product ID: 46708-095_4ea08829-6e98-4a5f-97d0-da2d1ac96dc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lamotrigine chewable dispersible
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA201168
Marketing category: ANDA
Marketing start: 2016-01-29
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 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
A201168-001	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB		2014-06-12
A201168-002	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB		2014-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201168-001	AB
A201168-002	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 · 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	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201168-001	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2014-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201168-002	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2014-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201168-001	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2014-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201168-002	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2014-06-12	`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	A201168-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201168-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201168-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201168-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201168-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201168-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201168-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201168-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201168-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201168-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201168-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201168-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201168-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201168-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201168-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201168-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201168-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201168-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201168-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201168-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201168-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201168-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201168-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201168-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201168-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201168-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201168-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201168-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201168-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201168-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201168-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201168-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201168-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201168-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201168-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201168-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201168-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201168-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201168-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201168-002	AB	1	`782e0a99824c…`

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 · 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
ae6522d4-d824-44aa-afe0-70cdcbd845af	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
46708-095-30	lamotrigine	30 in 1 BOTTLE	TABLET, FOR SUSPENSION	30	3
46708-095-31	lamotrigine	100 in 1 BOTTLE	TABLET, FOR SUSPENSION	100	3
46708-095-91	lamotrigine	1000 in 1 BOTTLE	TABLET, FOR SUSPENSION	1000	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-095	LAMOTRIGINE (LAMOTRIGINE CHEWABLE DISPERSIBLE) TABLET, FOR SUSPENSION [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 3 package rows	20230119_ae6522d4-d824-44aa-afe0-70cdcbd845af.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	Alembic Pharmaceuticals Inc.	05cba628-b12c-44d8-89a8-3522fe417cc1	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201168 application number: ANDA201168
lamotrigine	LAMOTRIGINE CHEWABLE DISPERSIBLE	Alembic Pharmaceuticals Limited	ae6522d4-d824-44aa-afe0-70cdcbd845af	2023-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201168 application number: ANDA201168 ndc (product): 46708-095

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	ae6522d4-d824-44aa-afe0-70cdcbd845af	3
311265	lamoTRIgine 5 MG Tablet for Oral Suspension	PSN	ae6522d4-d824-44aa-afe0-70cdcbd845af	3
311264	lamotrigine 25 MG Tablet for Oral Suspension	SCD	ae6522d4-d824-44aa-afe0-70cdcbd845af	3
311265	lamotrigine 5 MG Tablet for Oral Suspension	SCD	ae6522d4-d824-44aa-afe0-70cdcbd845af	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-095-30	46708009530	30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-30)	2016-01-29	0000-00-00	No	No	Current
46708-095-31	46708009531	100 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-31)	2016-01-29	0000-00-00	No	No	Current
46708-095-91	46708009591	1000 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-91)	2016-01-29	0000-00-00	No	No	Current