68462-243 NDC - LAMOTRIGINE ()

Drug Information

Field Name	Field Value
Labeler Name:	Glenmark Pharmaceuticals Inc., USA
Product Type:
FDA Application Number:	ANDA090169
Marketing Category:	ANDA
Start Marketing Date:	5/4/2012
End Marketing Date:	9/11/2019

No.	Package Code	Package Description	Billing Unit
1	68462-243-01	100 TABLET in 1 BOTTLE (68462-243-01)	EA
2	68462-243-10	1000 TABLET in 1 BOTTLE (68462-243-10)
3	68462-243-30	30 TABLET in 1 BOTTLE (68462-243-30)

Field Name	Field Value	Definition
PRODUCT NDC	68462-243	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAME	Lamotrigine	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	5/4/2012	This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE	9/11/2019	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAME	ANDA	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
APPLICATION NUMBER	ANDA090169	The translation of the dosage form Code submitted by the firm.
LABELER NAME	Glenmark Pharmaceuticals Inc., USA	The translation of the route code submitted by the firm, indicating route of administration.