LAMOTRIGINE

Product NDC: 43063-203
11-digit product format: 430630203
Labeler code: 43063
Product ID: 43063-203_508c7bfa-a4ab-5dcf-e063-6394a90a5402
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LAMOTRIGINE
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA078947
Marketing category: ANDA
Marketing start: 2009-01-27
Substance: LAMOTRIGINE
Active strength: 100 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 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
A078947-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A078947-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A078947-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A078947-004	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
A078947-001	AB
A078947-002	AB
A078947-003	AB
A078947-004	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	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-004	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	A078947-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078947-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078947-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-004	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	100 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
198427	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
f31e1854-6068-4e45-b1e5-6def862fc466	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
43063-203-30	LAMOTRIGINE	30 in 1 BOTTLE, PLASTIC	TABLET	30	27
43063-203-60	LAMOTRIGINE	60 in 1 BOTTLE, PLASTIC	TABLET	60	27
43063-203-90	LAMOTRIGINE	90 in 1 BOTTLE, PLASTIC	TABLET	90	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-203-30	EA - Each	43063-203	15d8aa4f-56fc-4c4c-a87e-5392553599ce	1	2012-07-24
43063-203-60	EA - Each	43063-203	a8dae20d-2459-48cf-913b-5c90e875ec86	1	2019-04-11
43063-203-90	EA - Each	43063-203	5fd1a60d-ab83-433e-8eb7-d0f6afb217f0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE (LAMOTRIGINE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	4
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE (LAMOTRIGINE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-203	LAMOTRIGINE TABLET [PD-RX PHARMACEUTICALS, INC.]	25	Current NDC, Legacy NDC, 3 package rows	20240922_f31e1854-6068-4e45-b1e5-6def862fc466.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	1d7c2d52-a78e-4508-8853-ba306cdeeaba	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	Torrent Pharmaceuticals Limited	3448839b-4933-4ef9-a80a-9e504d2c5696	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	50d46278-636a-470e-afcc-d3c8bd844e46	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	PD-Rx Pharmaceuticals, Inc.	f31e1854-6068-4e45-b1e5-6def862fc466	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947 ndc (product): 43063-203
LAMOTRIGINE	LAMOTRIGINE	PD-Rx Pharmaceuticals, Inc.	c638ab70-05dd-4f8b-9a11-b33a75f8c504	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE Kit	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	474fb321-575c-4b97-9dbe-080061652ee4	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	7ad18b68-ba16-4810-9c3e-27fa970454e8	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	Northwind Health Company, LLC	f7587283-781b-e111-e053-6394a90ad4cc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	NuCare Pharmaceuticals,Inc.	1bbbe2a2-a9e8-8c13-e063-6394a90a9627	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	A-S Medication Solutions	4e6cc1ad-55cd-4c7f-878c-fa6716e95897	2023-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947

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	f31e1854-6068-4e45-b1e5-6def862fc466	27
198427	lamotrigine 100 MG Oral Tablet	SCD	f31e1854-6068-4e45-b1e5-6def862fc466	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-203-30	43063020330	30 TABLET in 1 BOTTLE, PLASTIC (43063-203-30)	30 tablet	2010-08-13	0000-00-00	No	No	Current
43063-203-60	43063020360	60 TABLET in 1 BOTTLE, PLASTIC (43063-203-60)	60 tablet	2010-08-13	0000-00-00	No	No	Current
43063-203-90	43063020390	90 TABLET in 1 BOTTLE, PLASTIC (43063-203-90)	90 tablet	2010-08-13	0000-00-00	No	No	Current