0254-2053 NDC - CHLORZOXAZONE

Drug Information

  • Product NDC: 0254-2053
  • Proprietary Name: Chlorzoxazone
  • Non Proprietary Name: Chlorzoxazone
  • Active Ingredient(s): 375 mg/1 CHLORZOXAZONE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Centrally-mediated Muscle Relaxation [PE]; Muscle Relaxant [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Endo USA, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA212743
Marketing Category: ANDA
Start Marketing Date:6/17/2021

Package Information

No. Package Code Package Description Billing Unit
10254-2053-01100 TABLET in 1 BOTTLE (0254-2053-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0254-2053Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGAn 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.
PROPRIETARY NAMEChlorzoxazoneThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEChlorzoxazoneThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/17/2021This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NUMBERANDA212743This 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.
LABELER NAMEEndo USA, 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.
SUBSTANCE NAMECHLORZOXAZONEThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ACTIVE NUMERATOR STRENGTH375 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCentrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] 

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

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