Lamotrigine

Product NDC: 33261-648
11-digit product format: 332610648
Labeler code: 33261
Product ID: 33261-648_3ccfd582-29b5-4ea0-8f3b-2bd4fca4ace0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA090170
Marketing category: ANDA
Marketing start: 2011-11-01
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 100 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
33261-648-90	2020-01-31	C162847	48780-1	9d75b9d0-4993-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use lamotrigine tablets USP safely and effectively. See full prescribing information for lamotrigine tablets USP. Lamotrigine Tablets USP Initial U.S. Approval: 1994

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-648-90	Lamotrigine	90 in 1 BOTTLE, PLASTIC	TABLET	90		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-648	LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20140110_6d3f37b6-ad2e-470e-be6a-3de98479a941.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
198427	lamoTRIgine 100 MG Oral Tablet	PSN	6d3f37b6-ad2e-470e-be6a-3de98479a941	1
198427	lamotrigine 100 MG Oral Tablet	SCD	6d3f37b6-ad2e-470e-be6a-3de98479a941	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-648-90	33261064890	90 in 1 BOTTLE, PLASTIC	Historical