LAMOTRIGINE

Product NDC: 50436-0149
11-digit product format: 504360149
Labeler code: 50436
Product ID: 50436-0149_35004c15-2ff1-4184-b6cb-4d3ec7af6098
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA077783
Marketing category: ANDA
Marketing start: 2010-11-01
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: 2020-12-31
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
50436-0149-1	2021-01-29	C162847	48780-1	ba0f9c33-22b5-a910-e053-dadaa90a0b85	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, for oral use Initial U.S. Approval:1994

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0149-1	LAMOTRIGINE	30 in 1 BOTTLE	TABLET	30		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-0149-1	EA - Each	50436-0149	70c71d73-2fdc-46a3-ab71-44062debc48e	1	2017-11-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0149	LAMOTRIGINE TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20171011_c578d89a-7ea6-4927-af1a-a39e975d4fa7.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	c578d89a-7ea6-4927-af1a-a39e975d4fa7	2
198427	lamotrigine 100 MG Oral Tablet	SCD	c578d89a-7ea6-4927-af1a-a39e975d4fa7	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0149-1	50436014901	30 in 1 BOTTLE	Historical