0517-0131 NDC - DEXPANTHENOL ()

Drug Information

  • Product NDC: 0517-0131
  • Proprietary Name: Dexpanthenol
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: American Regent, Inc.
Product Type:
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:8/20/1993
End Marketing Date:11/9/2016

Package Information

No. Package Code Package Description Billing Unit
10517-0131-2525 VIAL, SINGLE-DOSE in 1 TRAY (0517-0131-25) / 2 mL in 1 VIAL, SINGLE-DOSEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0517-0131This is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAMEDexpanthenolThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/20/1993This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE11/9/2016Product 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.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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 NAMEAmerican Regent, Inc.This 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.

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This page was last updated on: 4/4/2025

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