Lamotrigine

Product NDC: 68788-6868
11-digit product format: 687886868
Labeler code: 68788
Product ID: 68788-6868_bde8497d-bb56-45af-b109-790bba94e2ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA202383
Marketing category: ANDA
Marketing start: 2017-01-11
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-6868		D	Discontinued by firm	2026-08-11
excluded package	package	68788-6868	68788-6868-1	D	Discontinued by firm	2026-08-11
excluded package	package	68788-6868	68788-6868-2	D	Discontinued by firm	2026-08-11
excluded package	package	68788-6868	68788-6868-3	D	Discontinued by firm	2026-08-11
excluded package	package	68788-6868	68788-6868-6	D	Discontinued by firm	2026-08-11
excluded package	package	68788-6868	68788-6868-8	D	Discontinued by firm	2026-08-11
excluded package	package	68788-6868	68788-6868-9	D	Discontinued by firm	2026-08-11

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 · 14 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	68788-6868-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6868-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6868-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6868-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6868-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-6868-8	`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	68788-6868-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6868-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6868-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6868-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6868-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-6868-8	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-6868-6	EA - Each	68788-6868	7ebc748b-6244-47c0-93be-fb404cb356a4	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-6868	LAMOTRIGINE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]	9	Legacy NDC	20240607_b7fd8b02-5699-48ae-a044-157894438cf0.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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3H27498KS	LAMOTRIGINE	84057-84-1	LAMOTRIGINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-6868-1	68788686801	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-1)	2017-01-11	0000-00-00	No	No	Current
68788-6868-2	68788686802	20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-2)	2017-01-11	0000-00-00	No	No	Current
68788-6868-3	68788686803	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-3)	2017-01-11	0000-00-00	No	No	Current
68788-6868-6	68788686806	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-6)	2017-01-11	0000-00-00	No	No	Current
68788-6868-8	68788686808	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-8)	2017-01-11	0000-00-00	No	No	Current
68788-6868-9	68788686809	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-9)	2017-01-11	0000-00-00	No	No	Current