53489-506 NDC - TOLMETIN SODIUM ()

Drug Information

  • Product NDC: 53489-506
  • Proprietary Name: TOLMETIN SODIUM
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Sun Pharmaceutical Industries, Inc.
Product Type:
FDA Application Number: ANDA073311
Marketing Category: ANDA
Start Marketing Date:9/4/2009
End Marketing Date:9/30/2009

Package Information

No. Package Code Package Description Billing Unit
153489-506-01100 TABLET in 1 BOTTLE, PLASTIC (53489-506-01)EA
253489-506-0250 TABLET in 1 BOTTLE, PLASTIC (53489-506-02)
353489-506-03250 TABLET in 1 BOTTLE, PLASTIC (53489-506-03)
453489-506-05500 TABLET in 1 BOTTLE, PLASTIC (53489-506-05)
553489-506-101000 TABLET in 1 BOTTLE, PLASTIC (53489-506-10)
653489-506-9090 TABLET in 1 BOTTLE, PLASTIC (53489-506-90)

NDC Record

Field Name Field Value Definition
PRODUCT NDC53489-506The 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 NAMETOLMETIN SODIUMA 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 DATE9/4/2009The translation of the dosage form Code submitted by the firm.
END MARKETING DATE9/30/2009The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAMEANDAThis is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBERANDA073311Product 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 NAMESun Pharmaceutical Industries, Inc.The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

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

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