Lamotrigine

Product NDC: 68071-2729
11-digit product format: 680712729
Labeler code: 68071
Product ID: 68071-2729_dfb46870-2ea4-58f8-e053-2995a90a0d71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA090170
Marketing category: ANDA
Marketing start: 2011-11-01
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 150 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: 2023-12-31
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
68071-2729-6	2025-01-30	C162847	48780-1	2cef2736-ad64-d83d-e063-dadaa90ab31f	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, for oral use Initial U.S. Approval: 1994

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2729-6	Lamotrigine	60 in 1 BOTTLE, PLASTIC	TABLET	60		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2729	LAMOTRIGINE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220524_dfb46870-2ea3-58f8-e053-2995a90a0d71.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
198428	lamoTRIgine 150 MG Oral Tablet	PSN	dfb46870-2ea3-58f8-e053-2995a90a0d71	1
198428	lamotrigine 150 MG Oral Tablet	SCD	dfb46870-2ea3-58f8-e053-2995a90a0d71	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2729-6	68071272906	60 TABLET in 1 BOTTLE, PLASTIC (68071-2729-6)	60 tablet	2022-05-23	0000-00-00	No	No	Current