54868-5742 NDC - OXYBUTYNIN CHLORIDE ()

Drug Information

  • Product NDC: 54868-5742
  • Proprietary Name: Oxybutynin Chloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Physicians Total Care, Inc.
Product Type:
FDA Application Number: ANDA076702
Marketing Category: ANDA
Start Marketing Date:1/8/2007

Package Information

No. Package Code Package Description Billing Unit
154868-5742-010 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-5742-0)EA
254868-5742-130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-5742-1)EA
354868-5742-260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-5742-2)EA
454868-5742-390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-5742-3)

NDC Record

Field Name Field Value Definition
PRODUCT NDC54868-5742This is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAMEOxybutynin ChlorideThis 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.
START MARKETING DATE1/8/2007Product 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 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 NUMBERANDA076702 
LABELER NAMEPhysicians Total Care, Inc.Product 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.

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

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