Lamotrigine

Product NDC: 68382-007
11-digit product format: 683820007
Labeler code: 68382
Product ID: 68382-007_277200d5-a863-4411-8c1b-aac8d7fde6a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA077633
Marketing category: ANDA
Marketing start: 2009-01-27
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: 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077633-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A077633-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27
A077633-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A077633-004	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A077633-005	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27
A077633-006	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077633-001	AB
A077633-003	AB
A077633-004	AB
A077633-005	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 7 · 246 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	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-005	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-006	LAMOTRIGINE	250MG	TABLET / ORAL		2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-002	LAMOTRIGINE	50MG	TABLET / ORAL		2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-003	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-004	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`

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	A077633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077633-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077633-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077633-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077633-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077633-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077633-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077633-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077633-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077633-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077633-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077633-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077633-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077633-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077633-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077633-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077633-005	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lamotrigine
Listing expiration: 2026-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198427	Internal RxNorm lookup
198428	Internal RxNorm lookup
198429	Internal RxNorm lookup
199322	Internal RxNorm lookup
249329	Internal RxNorm lookup
282401	Internal RxNorm lookup
311264	Internal RxNorm lookup
311265	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
e849033b-a3bc-408e-88de-7cd1d2660949	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
68382-007-01	Lamotrigine	100 in 1 BOTTLE	TABLET	100	29
68382-007-05	Lamotrigine	500 in 1 BOTTLE	TABLET	500	29
68382-007-10	Lamotrigine	1000 in 1 BOTTLE	TABLET	1000	29
68382-007-16	Lamotrigine	90 in 1 BOTTLE	TABLET	90	29

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
BLACK CURRANT	INACTIVE INGREDIENT	9755T40D11	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS (USA) INC.]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-007	LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS USA INC.]	28	Current NDC, Legacy NDC, 4 package rows	20250510_e849033b-a3bc-408e-88de-7cd1d2660949.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	American Health Packaging	35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	15d801a0-f0a5-40c1-bc88-d5ba9a02c696	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Cardinal Health 107, LLC	20e156df-a2b6-4710-b526-0419cd17dd33	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Major Pharmaceuticals	12e0be85-0961-4fe0-b973-83251ecf0f65	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	American Health Packaging	6034a8b8-9e80-43ca-b84f-ea82f788268c	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals Inc.	634dbe6c-4874-4d54-aa25-be02d3341f16	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Quallent Pharmaceuticals Health LLC	7977c87f-b459-486a-9edc-0a2071c46f4c	2026-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Northwind Health Company, LLC	03fd8413-df56-50ab-e063-6394a90a6950	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Northstar Rx LLC.	aabc64fe-1f17-4140-81f2-7d4506db6c8b	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Cardinal Health 107, LLC	beb24a4f-ab0b-435a-b60b-2b8d565ecd75	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Zydus Pharmaceuticals USA Inc.	e849033b-a3bc-408e-88de-7cd1d2660949	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633 ndc (product): 68382-007
Lamotrigine	LAMOTRIGINE	Zydus Lifesciences Limited	0f2f7421-56d4-45d0-9d2d-dc1edaede039	2025-10-04		Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	2cf33586-e48a-4b4e-b14b-33de2be63c1d	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	4bbc140c-6092-416d-865d-49b89c5ecdd0	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	cf03f130-067f-401c-8501-0d78a989a319	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	NuCare Pharmaceuticals,Inc.	065e97c9-3c5f-16e6-e063-6294a90a13fc	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	NCS HealthCare of KY, LLC dba Vangard Labs	e243e803-e95f-47a6-a6da-5fed657f4462	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	5a9575bb-230e-46ae-b58e-41554bad45eb	2023-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077633 application number: ANDA077633

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	e849033b-a3bc-408e-88de-7cd1d2660949	29
198428	lamoTRIgine 150 MG Oral Tablet	PSN	e849033b-a3bc-408e-88de-7cd1d2660949	29
198429	lamoTRIgine 200 MG Oral Tablet	PSN	e849033b-a3bc-408e-88de-7cd1d2660949	29
282401	lamoTRIgine 25 MG Oral Tablet	PSN	e849033b-a3bc-408e-88de-7cd1d2660949	29
311264	lamoTRIgine 25 MG Tablet for Oral Suspension	PSN	e849033b-a3bc-408e-88de-7cd1d2660949	29
249329	lamoTRIgine 250 MG Oral Tablet	PSN	e849033b-a3bc-408e-88de-7cd1d2660949	29
311265	lamoTRIgine 5 MG Tablet for Oral Suspension	PSN	e849033b-a3bc-408e-88de-7cd1d2660949	29
199322	lamoTRIgine 50 MG Oral Tablet	PSN	e849033b-a3bc-408e-88de-7cd1d2660949	29
198427	lamotrigine 100 MG Oral Tablet	SCD	e849033b-a3bc-408e-88de-7cd1d2660949	29
198428	lamotrigine 150 MG Oral Tablet	SCD	e849033b-a3bc-408e-88de-7cd1d2660949	29
198429	lamotrigine 200 MG Oral Tablet	SCD	e849033b-a3bc-408e-88de-7cd1d2660949	29
282401	lamotrigine 25 MG Oral Tablet	SCD	e849033b-a3bc-408e-88de-7cd1d2660949	29
311264	lamotrigine 25 MG Tablet for Oral Suspension	SCD	e849033b-a3bc-408e-88de-7cd1d2660949	29
249329	lamotrigine 250 MG Oral Tablet	SCD	e849033b-a3bc-408e-88de-7cd1d2660949	29
311265	lamotrigine 5 MG Tablet for Oral Suspension	SCD	e849033b-a3bc-408e-88de-7cd1d2660949	29
199322	lamotrigine 50 MG Oral Tablet	SCD	e849033b-a3bc-408e-88de-7cd1d2660949	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-007-01	68382000701	100 TABLET in 1 BOTTLE (68382-007-01)	100 tablet	2009-01-27	0000-00-00	No	No	Current
68382-007-05	68382000705	500 TABLET in 1 BOTTLE (68382-007-05)	500 tablet	2009-01-27	0000-00-00	No	No	Current
68382-007-10	68382000710	1000 TABLET in 1 BOTTLE (68382-007-10)	1000 tablet	2009-01-27	0000-00-00	No	No	Current
68382-007-16	68382000716	90 TABLET in 1 BOTTLE (68382-007-16)	90 tablet	2009-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	29