Lamotrigine

Product NDC: 70518-4121
11-digit product format: 705184121
Labeler code: 70518
Product ID: 70518-4121_4d65e768-faa2-1d32-e063-6394a90a93dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202383
Marketing category: ANDA
Marketing start: 2024-07-10
Substance: LAMOTRIGINE
Active strength: 50 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-4121-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-4121-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
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 · 254 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	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202383-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 254 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	A202383-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202383-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202383-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202383-006	AB	1	`caaa826d4ba7…`
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…`

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	50 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
850091	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
260dc37d-6e64-4688-82dc-10a1a428af17	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
70518-4121-0	Lamotrigine	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4121	LAMOTRIGINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]	1	Current NDC, 1 package rows	20240702_260dc37d-6e64-4688-82dc-10a1a428af17.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 ndc (product): 70518-4121
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

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
850091	lamoTRIgine 50 MG 24HR Extended Release Oral Tablet	PSN	260dc37d-6e64-4688-82dc-10a1a428af17	4
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	260dc37d-6e64-4688-82dc-10a1a428af17	4
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	260dc37d-6e64-4688-82dc-10a1a428af17	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4121-0	70518412100	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4121-0)	2024-07-10	No	No	Current