Lamotrigine

Product NDC: 82804-068
Requested package NDC: 82804-068-90
11-digit product format: 828040068
Labeler code: 82804
Product ID: 82804-068_6f7e59d2-4311-42a0-93a0-b29b0417d96f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090170
Marketing category: ANDA
Marketing start: 2011-11-01
Substance: LAMOTRIGINE
Active strength: 200 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 · 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.

Additional Listing Data#

Finished product: Yes
Brand name base: Lamotrigine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMOTRIGINE	200 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
198429	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
6f7e59d2-4311-42a0-93a0-b29b0417d96f	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	SPL version
82804-068-30	Lamotrigine	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
82804-068-60	Lamotrigine	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
82804-068-90	Lamotrigine	90 in 1 BOTTLE, PLASTIC	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-068-30	EA - Each	82804-068	954c1fd5-2cba-450b-affa-6ed2d1b1ba86	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-068	LAMOTRIGINE TABLET [PROFICIENT RX LP]	1	Current NDC, 3 package rows	20240208_6f7e59d2-4311-42a0-93a0-b29b0417d96f.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 ndc (package): 82804-068-90 ndc (product): 82804-068 ndc11 (package): 82804006890
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198429	lamoTRIgine 200 MG Oral Tablet	PSN	6f7e59d2-4311-42a0-93a0-b29b0417d96f	1
198429	lamotrigine 200 MG Oral Tablet	SCD	6f7e59d2-4311-42a0-93a0-b29b0417d96f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-068-90	82804006890	90 TABLET in 1 BOTTLE, PLASTIC (82804-068-90)	90 tablet	2024-01-31	No	No	Current