23710-100 NDC - ECOZA (ECONAZOLE NITRATE)

Drug Information

Product NDC: 23710-100

Proprietary Name: ECOZA

Non Proprietary Name: econazole nitrate

Active Ingredient(s):
  • 10 mg/g ECONAZOLE NITRATE


Administration Route(s): TOPICAL

Dosage Form(s): AEROSOL, FOAM

Pharmacy Class(es):
  • Azole Antifungal [EPC];
  • Azoles [CS]

Labeler Information

Labeler Name: Exeltis USA Dermatology, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA205175
Marketing Category: NDA
Start Marketing Date:10/2/2020

Package Information

No. Package Code Package Description Billing Unit
123710-100-701 CANISTER in 1 CARTON (23710-100-70) / 70 g in 1 CANISTERGM

NDC Record

Field Name Field Value Definition
PRODUCT NDC23710-100The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEECOZAThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEeconazole nitrateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEAEROSOL, FOAMThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/2/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA205175This 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.
LABELER NAMEExeltis USA Dermatology, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEECONAZOLE NITRATEAn 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.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmg/g 
PHARM CLASSESAzole Antifungal [EPC], Azoles [CS] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 2/1/2023