70260-430 NDC - PYRIMETHAMINE LEUCOVORIN ()

Drug Information

Field Name	Field Value
Labeler Name:	South Coast Specialty Compounding, Inc. d/b/a Park Compounding
Product Type:
FDA Application Number:
Marketing Category:	UNAPPROVED DRUG OTHER
Start Marketing Date:	11/25/2015

No.	Package Code	Package Description	Billing Unit
1	70260-430-01	100 CAPSULE in 1 BOTTLE (70260-430-01)

Field Name	Field Value	Definition
PRODUCT NDC	70260-430	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Pyrimethamine Leucovorin	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	11/25/2015	Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAME	UNAPPROVED DRUG OTHER	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.
LABELER NAME	South Coast Specialty Compounding, Inc. d/b/a Park Compounding	The translation of the route code submitted by the firm, indicating route of administration.