Lamotrigine

Product NDC: 50090-5828
11-digit product format: 500905828
Labeler code: 50090
Product ID: 50090-5828_ce17f544-8282-4f1c-86b0-21193b8b2601
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077633
Marketing category: ANDA
Marketing start: 2009-01-27
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: 2022-12-31
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
50090-5828-0	2023-01-30	C162847	48780-1	f386c64a-3c8f-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS FOR ORAL SUSPENSION. LAMOTRIGINE tablets, for oral use LAMOTRIGINE tablets for oral suspension Initial U.S. Approval: 1994

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5828-0	Lamotrigine	1 in 1 BLISTER PACK	TABLET	1		10
50090-5828-0	Lamotrigine	32 in 1 BOX, UNIT-DOSE	TABLET	32		10

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5828	LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]	10	Legacy NDC, 2 package rows	20211106_35418581-1942-44e1-ab92-0653fa5f3336.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	35418581-1942-44e1-ab92-0653fa5f3336	10
198427	lamotrigine 100 MG Oral Tablet	SCD	35418581-1942-44e1-ab92-0653fa5f3336	10

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5828-0	50090582800	32 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5828-0) > 1 TABLET in 1 BLISTER PACK	32 blister pack	2021-10-26	0000-00-00	No	No	Current