42934-103 NDC - LACOSAMIDE ()

Drug Information

Field Name	Field Value
Labeler Name:	Medley Pharmaceuticals Limited
Product Type:
FDA Application Number:	ANDA218014
Marketing Category:	ANDA
Start Marketing Date:	9/30/2022
End Marketing Date:	9/3/2024

No.	Package Code	Package Description	Billing Unit
1	42934-103-31	6 BLISTER PACK in 1 CARTON (42934-103-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK
2	42934-103-51	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42934-103-51)

Field Name	Field Value	Definition
PRODUCT NDC	42934-103	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	Lacosamide	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	9/30/2022	This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE	9/3/2024	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.
MARKETING CATEGORY NAME	ANDA	The translation of the dosage form Code submitted by the firm.
APPLICATION NUMBER	ANDA218014	The translation of the route code submitted by the firm, indicating route of administration.
LABELER NAME	Medley Pharmaceuticals Limited	This is the date that the labeler indicates was the start of its marketing of the drug product.