Lamotrigine

Product NDC: 16714-627
11-digit product format: 167140627
Labeler code: 16714
Product ID: 16714-627_9c4867cc-d291-bb7a-2942-69dab9cede75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA202383
Marketing category: ANDA
Marketing start: 2017-06-20
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: 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202383-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19
A202383-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19
A202383-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19
A202383-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19
A202383-005	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19
A202383-006	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202383-001	AB
A202383-002	AB
A202383-003	AB
A202383-004	AB
A202383-005	AB
A202383-006	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 · 242 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	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 242 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	A202383-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202383-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202383-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202383-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202383-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202383-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202383-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202383-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202383-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202383-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202383-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202383-004	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	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 · 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
9ab07d6b-ae4a-a310-5572-b266676cd29e	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
16714-627-01	Lamotrigine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-627-01	EA - Each	16714-627	cb2fc664-9aef-4e17-b421-26fdfdc4424a	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-627	LAMOTRIGINE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]	7	Current NDC, Legacy NDC, 1 package rows	20231227_9ab07d6b-ae4a-a310-5572-b266676cd29e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	260dc37d-6e64-4688-82dc-10a1a428af17	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202383 application number: ANDA202383
Lamotrigine	LAMOTRIGINE	Dr.Reddy's Laboratories Limited	a69542ea-5b6f-15c1-9e7a-90ac839971d3	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202383 application number: ANDA202383
Lamotrigine	LAMOTRIGINE	NorthStar Rx LLC	9ab07d6b-ae4a-a310-5572-b266676cd29e	2025-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202383 application number: ANDA202383 ndc (product): 16714-627

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	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
900164	lamoTRIgine 25 MG 24HR Extended Release Oral Tablet	PSN	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
1146690	lamoTRIgine 250 MG 24HR Extended Release Oral Tablet	PSN	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
850091	lamoTRIgine 50 MG 24HR Extended Release Oral Tablet	PSN	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
850087	24 HR lamotrigine 100 MG Extended Release Oral Tablet	SCD	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
900164	24 HR lamotrigine 25 MG Extended Release Oral Tablet	SCD	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
1146690	24 HR lamotrigine 250 MG Extended Release Oral Tablet	SCD	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
850087	lamotrigine 100 MG 24 HR Extended Release Oral Tablet	SY	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
900164	lamotrigine 25 MG 24 HR Extended Release Oral Tablet	SY	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
1146690	lamotrigine 250 MG 24 HR Extended Release Oral Tablet	SY	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	9ab07d6b-ae4a-a310-5572-b266676cd29e	8
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	9ab07d6b-ae4a-a310-5572-b266676cd29e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-627-01	16714062701	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-627-01)	2017-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine	NorthStar Rx LLC \| Dr.Reddy's Laboratories Limited	2025-11-20	HUMAN PRESCRIPTION DRUG LABEL	9