10370-209 NDC - FENOFIBRIC ACID ()

Drug Information

  • Product NDC: 10370-209
  • Proprietary Name: Fenofibric Acid
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Par Pharmaceutical, Inc.
Product Type:
FDA Application Number: ANDA201573
Marketing Category: ANDA
Start Marketing Date:7/18/2013
End Marketing Date:2/28/2021

Package Information

No. Package Code Package Description Billing Unit
110370-209-0990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (10370-209-09)EA
210370-209-101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (10370-209-10)

NDC Record

Field Name Field Value Definition
PRODUCT NDC10370-209The 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 NAMEFenofibric AcidThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXDelayed-ReleaseA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
START MARKETING DATE7/18/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE2/28/2021This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA201573This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEPar Pharmaceutical, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/26/2025

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