Lamotrigine

Product NDC: 42291-445
11-digit product format: 422910445
Labeler code: 42291
Product ID: 42291-445_485d3fe4-eadb-a4dc-e063-6294a90ab9f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: AvKARE
Application: ANDA207497
Marketing category: ANDA
Marketing start: 2020-05-22
Substance: LAMOTRIGINE
Active strength: 100 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207497-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A207497-001	AB
A207497-002	AB
A207497-003	AB
A207497-004	AB
A207497-005	AB
A207497-006	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 7 · 258 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	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A207497-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207497-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207497-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207497-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-004	AB	1	`b8a1b40f171c…`

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	100 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
850087	Internal RxNorm lookup
850091	Internal RxNorm lookup
900156	Internal RxNorm lookup
900164	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
a63e19c0-a093-e896-e053-2a95a90a7ccd	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
42291-445-30	Lamotrigine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-445-30	EA - Each	42291-445	376038f1-ad10-417d-b9d6-735e5b3812d8	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-445	LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE [AVKARE]	3	Current NDC, Legacy NDC, 1 package rows	20240110_a63e19c0-a093-e896-e053-2a95a90a7ccd.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	Amneal Pharmaceuticals LLC	0833d3df-2df1-4abd-abe0-7fb2c0253c80	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207497 application number: ANDA207497
Lamotrigine	LAMOTRIGINE	AvKARE	a63e19c0-a093-e896-e053-2a95a90a7ccd	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207497 application number: ANDA207497 ndc (product): 42291-445

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
850087	lamoTRIgine 100 MG 24HR Extended Release Oral Tablet	PSN	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
900164	lamoTRIgine 25 MG 24HR Extended Release Oral Tablet	PSN	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
1146690	lamoTRIgine 250 MG 24HR Extended Release Oral Tablet	PSN	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
850091	lamoTRIgine 50 MG 24HR Extended Release Oral Tablet	PSN	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
850087	24 HR lamotrigine 100 MG Extended Release Oral Tablet	SCD	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
900164	24 HR lamotrigine 25 MG Extended Release Oral Tablet	SCD	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
1146690	24 HR lamotrigine 250 MG Extended Release Oral Tablet	SCD	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
850087	lamotrigine 100 MG 24 HR Extended Release Oral Tablet	SY	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
900164	lamotrigine 25 MG 24 HR Extended Release Oral Tablet	SY	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
1146690	lamotrigine 250 MG 24 HR Extended Release Oral Tablet	SY	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	a63e19c0-a093-e896-e053-2a95a90a7ccd	4
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	a63e19c0-a093-e896-e053-2a95a90a7ccd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-445-30	42291044530	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-445-30)	2020-05-22	0000-00-00	No	No	Current