52125-100 NDC - GEMFIBROZIL ()

Drug Information

  • Product NDC: 52125-100
  • Proprietary Name: Gemfibrozil
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: REMEDYREPACK INC.
Product Type:
FDA Application Number: ANDA074256
Marketing Category: ANDA
Start Marketing Date:7/19/2012
End Marketing Date:8/24/2013

Package Information

No. Package Code Package Description Billing Unit
152125-100-0230 TABLET in 1 BLISTER PACK (52125-100-02)

NDC Record

Field Name Field Value Definition
PRODUCT NDC52125-100 
PROPRIETARY NAMEGemfibrozilIndicates 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.
START MARKETING DATE7/19/2012This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE8/24/2013The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAMEANDAThis is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBERANDA074256Product 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 NAMEREMEDYREPACK INC.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025