0085-0091 NDC - IMDUR ()

Drug Information

  • Product NDC: 0085-0091
  • Proprietary Name: IMDUR
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Schering Corporation
Product Type:
FDA Application Number: ANDA075155
Marketing Category: ANDA
Start Marketing Date:1/5/2006
End Marketing Date:4/6/2017

Package Information

No. Package Code Package Description Billing Unit
10085-0091-01100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0085-0091-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0085-0091The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PROPRIETARY NAMEIMDURThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/5/2006This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE4/6/2017Product 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 NAMEANDAName of Company corresponding to the labeler code segment of the Product NDC.
APPLICATION NUMBERANDA075155An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
LABELER NAMESchering Corporation 

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