Lamotrigine

Product NDC: 82804-105
Requested package NDC: 82804-105-60
11-digit product format: 828040105
Labeler code: 82804
Product ID: 82804-105_ffa46cb2-16e7-45f3-9940-5cb88d0cda9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA203370
Marketing category: ANDA
Marketing start: 2013-12-23
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

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
A203370-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203370-001	AB
A203370-002	AB
A203370-003	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	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 143 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	A203370-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203370-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203370-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203370-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203370-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203370-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203370-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203370-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203370-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203370-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203370-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203370-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203370-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203370-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203370-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203370-001	AB	1	`301d65b070ca…`

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
ffa46cb2-16e7-45f3-9940-5cb88d0cda9d	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
82804-105-30	Lamotrigine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	1
82804-105-60	Lamotrigine	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	1
82804-105-90	Lamotrigine	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-105-30	EA - Each	82804-105	381a107f-3048-4d59-921a-73125fefd2f0	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-105	LAMOTRIGINE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1	Current NDC, 3 package rows	20240517_ffa46cb2-16e7-45f3-9940-5cb88d0cda9d.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.	de7f61ca-e3c0-4a09-b664-0df2de6a0c30	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370
Lamotrigine	LAMOTRIGINE	Torrent Pharmaceuticals Limited	52df02a7-83da-4b20-9951-69790237dc24	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	ffa46cb2-16e7-45f3-9940-5cb88d0cda9d	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370 ndc (package): 82804-105-60 ndc (product): 82804-105 ndc11 (package): 82804010560

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	ffa46cb2-16e7-45f3-9940-5cb88d0cda9d	1
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	ffa46cb2-16e7-45f3-9940-5cb88d0cda9d	1
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	ffa46cb2-16e7-45f3-9940-5cb88d0cda9d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82804-105-60	82804010560	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-60)	2024-05-13	No	No	Current