Lamotrigine

Product NDC: 72789-206
11-digit product format: 727890206
Labeler code: 72789
Product ID: 72789-206_5b73e90b-d594-70c2-e063-6394a90ac8f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA090170
Marketing category: ANDA
Marketing start: 2011-11-01
Substance: LAMOTRIGINE
Active strength: 100 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 43.

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 · 172 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	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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090170-004	AB	1	`5bbf6a4d5a75…`

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	100 mg/1

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
72789-206-60	Lamotrigine	60 in 1 BOTTLE, PLASTIC	TABLET	60		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-206-60	EA - Each	72789-206	1e70ae3b-71aa-420b-97d3-605bfd926f4f	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-206	LAMOTRIGINE TABLET [PD-RX PHARMACEUTICALS, INC.]	25	Current NDC, Legacy NDC, 1 package rows	20240713_dc6e6735-d49a-44d8-936d-7c33437bc59e.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198427	lamoTRIgine 100 MG Oral Tablet	PSN	dc6e6735-d49a-44d8-936d-7c33437bc59e	27
198427	lamotrigine 100 MG Oral Tablet	SCD	dc6e6735-d49a-44d8-936d-7c33437bc59e	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-206-60	72789020660	60 TABLET in 1 BOTTLE, PLASTIC (72789-206-60)	60 tablet	2021-09-27	0000-00-00	No	No	Current