Lamotrigine

Product NDC: 0228-1638
11-digit product format: 002281638
Labeler code: 0228
Product ID: 0228-1638_49ac5dcd-9ccd-4e5a-9fdd-fe22a79c2770
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA200672
Marketing category: ANDA
Marketing start: 2016-06-01
Substance: LAMOTRIGINE
Active strength: 250 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 1.

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
A200672-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-005	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-006	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200672-001	AB
A200672-002	AB
A200672-003	AB
A200672-004	AB
A200672-005	AB
A200672-006	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 6 · 238 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	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 238 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	A200672-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200672-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lamotrigine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMOTRIGINE	250 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
87beaf22-593d-4170-bb58-332c615ef90d	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	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	Strength	SPL version
0228-1638-03	Lamotrigine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-1638-03	EA - Each	0228-1638	0085111a-8594-4332-b053-a8cadc271ab8	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-1638	LAMOTRIGINE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	24	Current NDC, Legacy NDC, 1 package rows	20250523_87beaf22-593d-4170-bb58-332c615ef90d.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	Actavis Pharma, Inc.	87beaf22-593d-4170-bb58-332c615ef90d	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200672 application number: ANDA200672 ndc (product): 0228-1638
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	36f383af-8b71-4875-85ef-3a7a8b1d8805	2024-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200672 application number: ANDA200672

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	87beaf22-593d-4170-bb58-332c615ef90d	28
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	87beaf22-593d-4170-bb58-332c615ef90d	28
900164	lamoTRIgine 25 MG 24HR Extended Release Oral Tablet	PSN	87beaf22-593d-4170-bb58-332c615ef90d	28
1146690	lamoTRIgine 250 MG 24HR Extended Release Oral Tablet	PSN	87beaf22-593d-4170-bb58-332c615ef90d	28
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	87beaf22-593d-4170-bb58-332c615ef90d	28
850091	lamoTRIgine 50 MG 24HR Extended Release Oral Tablet	PSN	87beaf22-593d-4170-bb58-332c615ef90d	28
850087	24 HR lamotrigine 100 MG Extended Release Oral Tablet	SCD	87beaf22-593d-4170-bb58-332c615ef90d	28
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	87beaf22-593d-4170-bb58-332c615ef90d	28
900164	24 HR lamotrigine 25 MG Extended Release Oral Tablet	SCD	87beaf22-593d-4170-bb58-332c615ef90d	28
1146690	24 HR lamotrigine 250 MG Extended Release Oral Tablet	SCD	87beaf22-593d-4170-bb58-332c615ef90d	28
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	87beaf22-593d-4170-bb58-332c615ef90d	28
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	87beaf22-593d-4170-bb58-332c615ef90d	28
850087	lamotrigine 100 MG 24 HR Extended Release Oral Tablet	SY	87beaf22-593d-4170-bb58-332c615ef90d	28
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	87beaf22-593d-4170-bb58-332c615ef90d	28
900164	lamotrigine 25 MG 24 HR Extended Release Oral Tablet	SY	87beaf22-593d-4170-bb58-332c615ef90d	28
1146690	lamotrigine 250 MG 24 HR Extended Release Oral Tablet	SY	87beaf22-593d-4170-bb58-332c615ef90d	28
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	87beaf22-593d-4170-bb58-332c615ef90d	28
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	87beaf22-593d-4170-bb58-332c615ef90d	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-1638-03	00228163803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1638-03)	2016-06-01	0000-00-00	No	No	Current