Lamotrigine

Product NDC: 29300-114
Requested package NDC: 29300-114-05
11-digit product format: 293000114
Labeler code: 29300
Product ID: 29300-114_03f59daf-b60e-46d1-b121-6a39361ee4f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 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
2026-02-19 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090170-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2011-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2011-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2011-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2011-10-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090170-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090170-004	AB	1	`d06236e962d9…`

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
198427	Internal RxNorm lookup
198428	Internal RxNorm lookup
198429	Internal RxNorm lookup
282401	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
4b72ea7a-a0b0-4980-84ad-84f64e2e6368	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
29300-114-05	Lamotrigine	500 in 1 BOTTLE, PLASTIC	TABLET	500	24
29300-114-10	Lamotrigine	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	24
29300-114-16	Lamotrigine	60 in 1 BOTTLE, PLASTIC	TABLET	60	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-114-05	EA - Each	29300-114	e77983d9-3f2c-4f03-a8cf-2e8cbb3bbadc	1	2013-02-13
29300-114-16	EA - Each	29300-114	62b5ba6c-f48f-4497-8166-da23ba4ddd7a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET [DIRECT RX]	1
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET [DIRECT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LAMOTRIGINE TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET [DIRECT RX]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	LAMOTRIGINE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMOTRIGINE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-114	LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	22	Current NDC, Legacy NDC, 3 package rows	20250529_4b72ea7a-a0b0-4980-84ad-84f64e2e6368.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	d1691a60-ff0a-4755-b445-1d78309d5af0	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	346f8af3-b850-48e4-bd6e-82ecafca86d2	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	f5761818-4eaf-4335-a77a-9cd703278ded	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	1b5646a9-4724-44b8-8cd0-9c14f5e87f86	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Coupler LLC	55f41c7e-03a6-b84c-e063-6294a90a7d82	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	3ed4590d-71e3-4208-b6c0-98330acc7b85	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Coupler LLC	545fcc0e-1e2b-bdcb-e063-6294a90a4ac7	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	b1601109-5c17-4482-9257-1e0be7546e8f	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Coupler LLC	52b8be5c-ef88-dfa7-e063-6394a90a0500	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Unichem Pharmaceuticals (USA), Inc.	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170 ndc (package): 29300-114-05 ndc (product): 29300-114 ndc11 (package): 29300011405
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals, Inc.	16323699-9bf8-43c7-b3aa-589156377872	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals Inc.	09a0d30d-9b8f-4c76-8cdb-8492386b2254	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	6139a858-700c-4eb9-9f84-99d280bde326	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	PD-Rx Pharmaceuticals, Inc.	dc6e6735-d49a-44d8-936d-7c33437bc59e	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	811188be-d231-4b58-8d7a-b01b236fab51	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Northwind Health Company, LLC	db5f7ee5-9bd9-1819-e053-2a95a90a91df	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	84277e2c-370c-4510-92bc-ef33a4a0f508	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	8e1e4fa8-881c-4618-88f6-018ab15db44d	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090170 application number: ANDA090170
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	53774022-ea0c-42a9-a720-dc755c77b851	2025-09-17	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	812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c	102
198429	lamotrigine 200 MG Oral Tablet	SCD	812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c	102
198427	lamoTRIgine 100 MG Oral Tablet	PSN	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	24
198428	lamoTRIgine 150 MG Oral Tablet	PSN	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	24
198429	lamoTRIgine 200 MG Oral Tablet	PSN	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	24
282401	lamoTRIgine 25 MG Oral Tablet	PSN	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	24
198427	lamotrigine 100 MG Oral Tablet	SCD	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	24
198428	lamotrigine 150 MG Oral Tablet	SCD	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	24
198429	lamotrigine 200 MG Oral Tablet	SCD	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	24
282401	lamotrigine 25 MG Oral Tablet	SCD	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	24
198429	lamoTRIgine 200 MG Oral Tablet	PSN	346f8af3-b850-48e4-bd6e-82ecafca86d2	15
198429	lamoTRIgine 200 MG Oral Tablet	PSN	3ed4590d-71e3-4208-b6c0-98330acc7b85	15
198429	lamotrigine 200 MG Oral Tablet	SCD	346f8af3-b850-48e4-bd6e-82ecafca86d2	15
198429	lamotrigine 200 MG Oral Tablet	SCD	3ed4590d-71e3-4208-b6c0-98330acc7b85	15
198429	lamoTRIgine 200 MG Oral Tablet	PSN	84277e2c-370c-4510-92bc-ef33a4a0f508	12
198429	lamotrigine 200 MG Oral Tablet	SCD	84277e2c-370c-4510-92bc-ef33a4a0f508	12
198429	lamoTRIgine 200 MG Oral Tablet	PSN	6f7e59d2-4311-42a0-93a0-b29b0417d96f	1
198429	lamoTRIgine 200 MG Oral Tablet	PSN	8ac9dc83-edb2-4ae5-8064-40f113fd3aab	1
198429	lamoTRIgine 200 MG Oral Tablet	PSN	0b9da408-7857-4ff8-86f9-ae56bfd0fe38	1
198429	lamotrigine 200 MG Oral Tablet	SCD	8ac9dc83-edb2-4ae5-8064-40f113fd3aab	1
198429	lamotrigine 200 MG Oral Tablet	SCD	6f7e59d2-4311-42a0-93a0-b29b0417d96f	1
198429	lamotrigine 200 MG Oral Tablet	SCD	0b9da408-7857-4ff8-86f9-ae56bfd0fe38	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-114-05	29300011405	500 TABLET in 1 BOTTLE, PLASTIC (29300-114-05)	500 tablet	2011-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine	REMEDYREPACK INC.	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	16
Lamotrigine	REMEDYREPACK INC.	2026-07-06	HUMAN PRESCRIPTION DRUG LABEL	16
Lamotrigine	Unichem Pharmaceuticals (USA), Inc.	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	25
Lamotrigine	A-S Medication Solutions	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	12
Lamotrigine	Bryant Ranch Prepack	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL	102
Lamotrigine	Preferred Pharmaceuticals Inc.	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	7
Lamotrigine	Proficient Rx LP	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	1
Lamotrigine	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-10-14	HUMAN PRESCRIPTION DRUG LABEL	1
LAMOTRIGINE	Direct RX	2015-07-02	HUMAN PRESCRIPTION DRUG LABEL	1