0078-0102 NDC - PARLODEL ()

Drug Information

Field Name	Field Value
Labeler Name:	Novartis Pharmaceuticals Corporation
Product Type:
FDA Application Number:	NDA017962
Marketing Category:	NDA
Start Marketing Date:	6/28/1978
End Marketing Date:	11/1/2014

No.	Package Code	Package Description	Billing Unit
1	0078-0102-05	100 CAPSULE in 1 PACKAGE (0078-0102-05)	EA
2	0078-0102-15	30 CAPSULE in 1 PACKAGE (0078-0102-15)	EA

Field Name	Field Value	Definition
PRODUCT NDC	0078-0102	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	Parlodel	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	6/28/1978	This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE	11/1/2014	The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAME	NDA	The translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBER	NDA017962	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	Novartis Pharmaceuticals Corporation	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.