42195-425 NDC - LEVAMLODIPINE ()

Drug Information

No.	Package Code	Package Description	Billing Unit
1	42195-425-30	30 TABLET in 1 BOTTLE (42195-425-30)	EA

Field Name	Field Value	Definition
PRODUCT NDC	42195-425	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME	Levamlodipine	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
START MARKETING DATE	8/15/2021	The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAME	NDA AUTHORIZED GENERIC	The translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBER	NDA212895	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	Xspire Pharma, LLC	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.