LAMOTRIGINE

Product NDC: 53808-1011
11-digit product format: 538081011
Labeler code: 53808
Product ID: 53808-1011_bf2a898c-4670-4d40-bec5-c704a5900523
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LAMOTRIGINE
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA078947
Marketing category: ANDA
Marketing start: 2014-11-01
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 25 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1011-1	2020-01-31	C162847	48780-1	9d75b9d0-861a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Lamotrigine Tablets safely and effectively. See full prescribing information for Lamotrigine Tablets Lamotrigine Tablets, USP Initial U.S. Approval: 1994

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1011-1	LAMOTRIGINE	30 in 1 BLISTER PACK	TABLET	30		1

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE (LAMOTRIGINE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE (LAMOTRIGINE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1011	LAMOTRIGINE (LAMOTRIGINE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20150107_3ace34cc-eac4-45a4-9c8e-b18e8157d98d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3H27498KS	LAMOTRIGINE	84057-84-1	LAMOTRIGINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
282401	lamoTRIgine 25 MG Oral Tablet	PSN	3ace34cc-eac4-45a4-9c8e-b18e8157d98d	1
282401	lamotrigine 25 MG Oral Tablet	SCD	3ace34cc-eac4-45a4-9c8e-b18e8157d98d	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-1011-1	53808101101	30 in 1 BLISTER PACK	Historical