NDC 51672-4130-01 - Lamotrigine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 51672-4130
Requested NDC: 51672-4130-01
Package NDCs from labels: 51672-4130-6, 51672-4130-4, 51672-4130-1, 51672-4130-3, 51672-4130-0, 51672-4130-01
Manufacturer: Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date: 2026-06-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Lamotrigine	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries Ltd.	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - REMEDYREPACK INC.	REMEDYREPACK INC.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - Preferred Pharmaeuticals Inc.	Preferred Pharmaeuticals Inc.	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - ST. MARY'S MEDICAL PARK PHARMACY	ST. MARY'S MEDICAL PARK PHARMACY	2022-07-27	HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - A-S Medication Solutions	A-S Medication Solutions	2018-07-26	HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - A-S Medication Solutions	A-S Medication Solutions	2018-06-12	HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2015-01-03	HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - Rebel Distributors Corp	Rebel Distributors Corp	2010-09-30	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-4130-0	Lamotrigine	10 in 1 BLISTER PACK	TABLET	10	21
51672-4130-0	Lamotrigine	10 in 1 CARTON	TABLET	10	21
51672-4130-1	Lamotrigine	100 in 1 BOTTLE	TABLET	100	21
51672-4130-3	Lamotrigine	1000 in 1 BOTTLE	TABLET	1000	21
51672-4130-4	Lamotrigine	60 in 1 BOTTLE	TABLET	60	21
51672-4130-6	Lamotrigine	30 in 1 BOTTLE	TABLET	30	21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4130	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	15	Current NDC, Legacy NDC, 6 package rows	20230517_b829f9b2-f0ac-408a-a6f4-18b72150227d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4130-1	EA - Each	51672-4130	b1138f13-a1a8-4495-a8a5-2c4d49568df5	1	2012-07-24
51672-4130-3	EA - Each	51672-4130	33c9112c-59c4-4d89-834e-19e4d2ec8233	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lamotrigine	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
Lamotrigine	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
crospovidone	INACTIVE INGREDIENT	68401960MK	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
povidones	INACTIVE INGREDIENT	FZ989GH94E	LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Lamotrigine	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
Lamotrigine	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C Blue NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

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 3 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	022b0913-f683-4af8-a862-f81b315909b2	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Sun Pharmaceutical Industries, Inc.	b829f9b2-f0ac-408a-a6f4-18b72150227d	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078525 ndc (package): 51672-4130-0 ndc (package): 51672-4132-2 ndc (package): 51672-4133-0 ndc (package): 51672-4132-3 ndc (package): 51672-4133-2 ndc (package): 51672-4133-6 ndc (package): 51672-4131-0 ndc (package): 51672-4131-6 ndc (package): 51672-4133-1 ndc (package): 51672-4130-4 ndc (package): 51672-4132-6 ndc (package): 51672-4130-1 ndc (package): 51672-4131-3 ndc (package): 51672-4131-1 ndc (package): 51672-4132-4 ndc (package): 51672-4130-3 ndc (package): 51672-4130-6 ndc (package): 51672-4132-1 ndc (package): 51672-4132-0 ndc (package): 51672-4131-4 ndc (package): 51672-4133-4 ndc (package): 51672-4133-3 ndc (product): 51672-4130 ndc (product): 51672-4132 ndc (product): 51672-4133 ndc (product): 51672-4131 ndc11 (package): 51672413001 rxcui: 282401 rxcui: 198428 rxcui: 198427 rxcui: 198429 spl id: 5356e9be-0f6c-ebbb-e063-6394a90aac4d spl set id: b829f9b2-f0ac-408a-a6f4-18b72150227d unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	68a4dac2-5015-40c5-88ca-204098c3b288	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078525 rxcui: 198428 unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Coupler LLC	52b8be5c-ef88-dfa7-e063-6394a90a0500	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 198427 unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Aurobindo Pharma Limited	a9a4309e-fe43-4a26-a30f-c6577d650336	2026-05-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 282401 rxcui: 198428 rxcui: 198427 rxcui: 198429 unii: U3H27498KS
Ripple	GLYCERIN, POVIDONE	CorneaCare Inc	3b5ba197-d501-681e-e063-6294a90aefb5	2026-05-24	Warnings	Exact identifier unii: FZ989GH94E
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Limited	ccb33cd0-e5f7-4a50-8b55-ad7c432cdb77	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 282401 rxcui: 198428 rxcui: 198427 rxcui: 198429 unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Unichem Pharmaceuticals (USA), Inc.	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 282401 rxcui: 198428 rxcui: 198427 rxcui: 198429 unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals, Inc.	16323699-9bf8-43c7-b3aa-589156377872	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 282401 unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals Inc.	09a0d30d-9b8f-4c76-8cdb-8492386b2254	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 198427 unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	AvKARE	fcdb94a8-33be-6375-98ef-6933999d157f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 282401 rxcui: 198428 rxcui: 198427 rxcui: 198429 unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Major Pharmaceuticals	12e0be85-0961-4fe0-b973-83251ecf0f65	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 282401 rxcui: 198427 unii: U3H27498KS
50c4c3a3-1a66-2094-e063-6294a90a2656			e55a986a-217f-678e-e053-2a95a90aa779	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier spl set id: e55a986a-217f-678e-e053-2a95a90aa779
iVIZIA Lubricant Eye Gel	POVIDONE	Thea Pharma Inc.	1f06ca1a-5270-9a82-e063-6294a90aed64	2026-04-29	Warnings	Exact identifier unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Preferred PHarmaceuticals Inc.	011473a8-26d5-4661-b3c0-745f9b6aa1d8	2026-04-29	Warnings	Exact identifier unii: FZ989GH94E
Lamotrigine	LAMOTRIGINE	Actavis Pharma, Inc.	87beaf22-593d-4170-bb58-332c615ef90d	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	REMEDYREPACK INC.	65748114-c59c-4ebb-977e-d4aab5764dd3	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS
Lamotrigine	LAMOTRIGINE	Par Health USA, LLC	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS
FreshKote Preservative Free Lubricant Eye Drops	POVIDONE, POLYVINYL ALCOHOL	Eyevance Pharmaceuticals	f51c50c3-43ae-4169-9d2b-22b239461dd1	2026-04-08	Warnings	Exact identifier unii: FZ989GH94E
Lamotrigine	LAMOTRIGINE	Nordic Pharma, Inc.	67cf961e-02b9-4a99-944f-43a55df6a544	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.