Lamotrigine

Product NDC: 10370-256
11-digit product format: 103700256
Labeler code: 10370
Product ID: 10370-256_4e8e57a4-ecd3-4fce-943c-1ad74ea1ecc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lamotrigine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA201374
Marketing category: ANDA
Marketing start: 2026-01-02
Substance: LAMOTRIGINE
Active strength: 300 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 44.

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
A201374-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201374-001	AB
A201374-002	AB
A201374-003	AB
A201374-004	AB
A201374-005	AB
A201374-006	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 · 264 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
2026-10-15 13:18:30	2026-09	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2012-12-26	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 186 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A201374-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201374-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201374-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201374-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201374-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201374-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201374-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201374-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201374-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201374-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201374-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201374-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201374-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201374-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201374-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201374-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201374-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201374-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201374-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201374-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201374-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201374-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201374-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201374-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201374-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201374-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201374-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201374-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201374-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201374-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201374-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201374-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201374-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201374-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201374-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201374-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201374-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201374-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201374-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201374-002	AB	1	`8869cabd3fbd…`

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
Brand name suffix: Extended-Release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMOTRIGINE	300 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
850087	Internal RxNorm lookup
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
d5ec4d58-c669-4ab4-ba62-b71007536854	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
10370-256-11	LamotrigineExtended-Release	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		7

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine Extended-Release	LAMOTRIGINE	Par Health USA, LLC	d5ec4d58-c669-4ab4-ba62-b71007536854	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201374 application number: ANDA201374 ndc (product): 10370-256

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	d5ec4d58-c669-4ab4-ba62-b71007536854	7
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	d5ec4d58-c669-4ab4-ba62-b71007536854	7
1146690	lamoTRIgine 250 MG 24HR Extended Release Oral Tablet	PSN	d5ec4d58-c669-4ab4-ba62-b71007536854	7
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	d5ec4d58-c669-4ab4-ba62-b71007536854	7
850087	24 HR lamotrigine 100 MG Extended Release Oral Tablet	SCD	d5ec4d58-c669-4ab4-ba62-b71007536854	7
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	d5ec4d58-c669-4ab4-ba62-b71007536854	7
1146690	24 HR lamotrigine 250 MG Extended Release Oral Tablet	SCD	d5ec4d58-c669-4ab4-ba62-b71007536854	7
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	d5ec4d58-c669-4ab4-ba62-b71007536854	7
850087	lamotrigine 100 MG 24 HR Extended Release Oral Tablet	SY	d5ec4d58-c669-4ab4-ba62-b71007536854	7
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	d5ec4d58-c669-4ab4-ba62-b71007536854	7
1146690	lamotrigine 250 MG 24 HR Extended Release Oral Tablet	SY	d5ec4d58-c669-4ab4-ba62-b71007536854	7
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	d5ec4d58-c669-4ab4-ba62-b71007536854	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
10370-256-11	10370025611	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-256-11)	2026-01-02	No	No	Current