Lamotrigine

Product NDC: 0093-0688
11-digit product format: 000930688
Labeler code: 0093
Product ID: 0093-0688_ab3cf2de-a729-47a2-a842-ab5bdaf72dca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA076420
Marketing category: ANDA
Marketing start: 2006-08-28
Marketing end: 2019-07-31
Substance: LAMOTRIGINE
Active strength: 5 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: 0000-00-00
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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0688-01	EA - Each	0093-0688	7d08df71-c436-42ca-acc8-0992f32f814b	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]	2

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
311265	lamoTRIgine 5 MG Tablet for Oral Suspension	PSN	a7455849-968d-4d85-8733-1e01701d7942	3
311265	lamotrigine 5 MG Tablet for Oral Suspension	SCD	a7455849-968d-4d85-8733-1e01701d7942	3