0245-0421 NDC - FENTANYL ()

Drug Information

  • Product NDC: 0245-0421
  • Proprietary Name: Fentanyl
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Upsher-Smith Laboratories, Inc.
Product Type:
FDA Application Number: ANDA077775
Marketing Category: ANDA
Start Marketing Date:3/1/2013
End Marketing Date:12/31/2015

Package Information

No. Package Code Package Description Billing Unit
10245-0421-055 POUCH in 1 CARTON (0245-0421-05) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH (0245-0421-89)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0245-0421Indicates 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 NAMEFentanylThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
START MARKETING DATE3/1/2013The translation of the dosage form Code submitted by the firm.
END MARKETING DATE12/31/2015This 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 NUMBERANDA077775This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMEUpsher-Smith Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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