Lamotrigine

Product NDC: 68788-7647
11-digit product format: 687887647
Labeler code: 68788
Product ID: 68788-7647_6b83b1eb-b236-4100-8b51-6e7e0d3dc11a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA090170
Marketing category: ANDA
Marketing start: 2020-04-17
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 150 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7647		D	Discontinued by firm	2026-10-16
excluded package	package	68788-7647	68788-7647-3	D	Discontinued by firm	2026-10-16
excluded package	package	68788-7647	68788-7647-6	D	Discontinued by firm	2026-10-16
excluded package	package	68788-7647	68788-7647-9	D	Discontinued by firm	2026-10-16

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 · 8 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	68788-7647-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7647-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7647-3	`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	68788-7647-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7647-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7647-3	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090170-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06
A090170-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06
A090170-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06
A090170-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090170-001	AB
A090170-002	AB
A090170-003	AB
A090170-004	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 5 · 176 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	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090170-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090170-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090170-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090170-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090170-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090170-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090170-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090170-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090170-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090170-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090170-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090170-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090170-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090170-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090170-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090170-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090170-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090170-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090170-004	AB	1	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7647-3	EA - Each	68788-7647	8589e742-e5bf-4d3c-a36c-e2b2e65b2f73	1	2020-06-05
68788-7647-6	EA - Each	68788-7647	eba98054-becd-4f10-a210-354e13839984	1	2020-06-05
68788-7647-9	EA - Each	68788-7647	d71b1a1a-fe59-416a-a589-f8fab5ada5c6	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7647	LAMOTRIGINE TABLET [PREFERRED PHARMACEUTICALS, INC.]	5	Legacy NDC	20240607_172fa34c-7b63-4fe8-bb7c-42380e4d933a.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	6f7e59d2-4311-42a0-93a0-b29b0417d96f	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	52273d60-3f27-4846-bf40-014ebcf09417	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	b94ae2e4-e276-40c1-bc25-da980194fc99	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Asclemed USA, Inc.	8ac9dc83-edb2-4ae5-8064-40f113fd3aab	2020-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7647-3	68788764703	30 TABLET in 1 BOTTLE, PLASTIC (68788-7647-3)	30 tablet	2020-04-17	0000-00-00	No	No	Current
68788-7647-6	68788764706	60 TABLET in 1 BOTTLE, PLASTIC (68788-7647-6)	60 tablet	2020-04-17	0000-00-00	No	No	Current
68788-7647-9	68788764709	90 TABLET in 1 BOTTLE, PLASTIC (68788-7647-9)	90 tablet	2020-04-17	0000-00-00	No	No	Current