Lamotrigine

Product NDC: 60760-543
11-digit product format: 607600543
Labeler code: 60760
Product ID: 60760-543_e55a9e50-61e8-2b3f-e053-2995a90a4b74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA078525
Marketing category: ANDA
Marketing start: 2022-07-27
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 25 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60760-543		D	Discontinued by firm		2026-08-11
excluded package	package	60760-543	60760-543-30	D	Discontinued by firm		2026-08-11

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
A078525-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A078525-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A078525-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A078525-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	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
A078525-001	AB
A078525-002	AB
A078525-003	AB
A078525-004	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	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`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	A078525-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078525-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078525-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-543-30	EA - Each	60760-543	7a05594e-eb67-4d40-aa35-c4aa91056fe6	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-543	LAMOTRIGINE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]	1	Legacy NDC	20220805_e55a986a-217f-678e-e053-2a95a90aa779.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	Sun Pharmaceutical Industries, Inc.	b829f9b2-f0ac-408a-a6f4-18b72150227d	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078525 application number: ANDA078525
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	68a4dac2-5015-40c5-88ca-204098c3b288	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078525 application number: ANDA078525
Lamotrigine	LAMOTRIGINE	NuCare Pharmaceuticals, Inc.	47fd2592-2fc6-9787-e063-6394a90a8f01	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078525 application number: ANDA078525

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	Marketing end	Sample	Exclude flag	Status
60760-543-30	60760054330	30 TABLET in 1 BOTTLE, PLASTIC (60760-543-30)	30 tablet	2022-07-27	0000-00-00	No	No	Current