68462-363 NDC - CLOBETASOL PROPIONATE ()

Drug Information

  • Product NDC: 68462-363
  • Proprietary Name: Clobetasol Propionate
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Glenmark Generics Inc., USA
Product Type:
FDA Application Number: ANDA075325
Marketing Category: ANDA
Start Marketing Date:3/1/2008
End Marketing Date:1/31/2011

Package Information

No. Package Code Package Description Billing Unit
168462-363-1715 g in 1 TUBE (68462-363-17)
268462-363-3530 g in 1 TUBE (68462-363-35)
368462-363-6560 g in 1 TUBE (68462-363-65)

NDC Record

Field Name Field Value Definition
PRODUCT NDC68462-363The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAMEClobetasol PropionateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/1/2008The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
END MARKETING DATE1/31/2011This 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 NUMBERANDA075325Name of Company corresponding to the labeler code segment of the Product NDC.
LABELER NAMEGlenmark Generics Inc., USAName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/19/2025

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