Lamotrigine

Product NDC: 46708-417
Requested package NDC: 46708-417-91
11-digit product format: 467080417
Labeler code: 46708
Product ID: 46708-417_faee013c-cad2-4abb-904c-e6ff79ba778c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA211821
Marketing category: ANDA
Marketing start: 2024-10-07
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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211821-001	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01
A211821-002	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01
A211821-003	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211821-001	AB
A211821-002	AB
A211821-003	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.

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	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211821-001	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211821-002	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211821-003	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-10-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211821-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211821-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211821-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211821-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211821-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211821-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211821-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211821-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211821-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211821-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211821-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211821-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211821-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211821-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211821-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211821-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211821-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211821-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211821-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211821-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211821-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211821-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211821-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211821-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211821-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211821-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211821-003	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211821-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211821-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211821-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211821-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211821-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211821-003	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211821-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211821-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211821-003	AB	1	`a50c72e98297…`

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: 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
900156	Internal RxNorm lookup
1098608	Internal RxNorm lookup
1146690	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
faee013c-cad2-4abb-904c-e6ff79ba778c	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
46708-417-30	Lamotrigine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1
46708-417-91	Lamotrigine	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-417	LAMOTRIGINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 2 package rows	20241013_faee013c-cad2-4abb-904c-e6ff79ba778c.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.	4bd7193f-a81a-4909-90c2-7f324fc6ddfd	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211821 application number: ANDA211821
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Limited	faee013c-cad2-4abb-904c-e6ff79ba778c	2024-10-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211821 application number: ANDA211821 ndc (package): 46708-417-91 ndc (product): 46708-417 ndc11 (package): 46708041791

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
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	faee013c-cad2-4abb-904c-e6ff79ba778c	1
1146690	lamoTRIgine 250 MG 24HR Extended Release Oral Tablet	PSN	faee013c-cad2-4abb-904c-e6ff79ba778c	1
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	faee013c-cad2-4abb-904c-e6ff79ba778c	1
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	faee013c-cad2-4abb-904c-e6ff79ba778c	1
1146690	24 HR lamotrigine 250 MG Extended Release Oral Tablet	SCD	faee013c-cad2-4abb-904c-e6ff79ba778c	1
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	faee013c-cad2-4abb-904c-e6ff79ba778c	1
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	faee013c-cad2-4abb-904c-e6ff79ba778c	1
1146690	lamotrigine 250 MG 24 HR Extended Release Oral Tablet	SY	faee013c-cad2-4abb-904c-e6ff79ba778c	1
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	faee013c-cad2-4abb-904c-e6ff79ba778c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
46708-417-91	46708041791	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-417-91)	2024-10-07	No	No	Current