LAMOTRIGINE

Product NDC: 84677-034
Requested package NDC: 84677-034-30
11-digit product format: 846770034
Labeler code: 84677
Product ID: 84677-034_57f04667-9929-f6b2-e063-6294a90abe40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA219677
Marketing category: ANDA
Marketing start: 2025-10-07
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 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
A219677-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07
A219677-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07
A219677-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07
A219677-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219677-001	AB
A219677-002	AB
A219677-003	AB
A219677-004	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.

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	A219677-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219677-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219677-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219677-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219677-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219677-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219677-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219677-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219677-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219677-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219677-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219677-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219677-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219677-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219677-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219677-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219677-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219677-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219677-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219677-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2025-10-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219677-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219677-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219677-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219677-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219677-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219677-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219677-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219677-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219677-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219677-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219677-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219677-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219677-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219677-004	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219677-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219677-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219677-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219677-004	AB	1	`a50c72e98297…`

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103968	Internal RxNorm lookup
198430	Internal RxNorm lookup
252478	Internal RxNorm lookup
252479	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
57f04b9b-06cd-8044-e063-6394a90ae733	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMOTRIGINE	LAMOTRIGINE	Golden State Medical Supply, Inc.	57f04b9b-06cd-8044-e063-6394a90ae733	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219677 application number: ANDA219677 ndc (package): 84677-034-30 ndc (product): 84677-034 ndc11 (package): 84677003430
LAMOTRIGINE	LAMOTRIGINE	Sun Pharmaceutical Industries, Inc.	83297e2e-9199-4b3d-9f44-a921787758fe	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219677 application number: ANDA219677

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	Sample	Exclude flag	Status
84677-034-30	84677003430	30 TABLET in 1 BOTTLE (84677-034-30)	30 tablet	2026-04-30	No	No	Current