55505-192 NDC - NIZORAL (KETOCONAZOLE)

Drug Information

Product NDC: 55505-192

Proprietary Name: Nizoral

Non Proprietary Name: Ketoconazole

Active Ingredient(s):
  • 10 mg/mL KETOCONAZOLE


Administration Route(s): TOPICAL

Dosage Form(s): SHAMPOO

Pharmacy Class(es):
  • Azole Antifungal [EPC];
  • Azoles [CS];
  • Cytochrome P450 3A4 Inhibitors [MoA];
  • Cytochrome P450 3A5 Inhibitors [MoA];
  • P-Glycoprotein Inhibitors [MoA]

Labeler Information

Labeler Name: Kramer Laboratories
Product Type: HUMAN OTC DRUG
FDA Application Number: NDA020310
Marketing Category: NDA
Start Marketing Date:1/7/2019

Package Information

No. Package Code Package Description Billing Unit
155505-192-331 BOTTLE in 1 CARTON (55505-192-33) / 125 mL in 1 BOTTLEML
255505-192-401 BOTTLE in 1 CARTON (55505-192-40) / 200 mL in 1 BOTTLEML
355505-192-572 CARTON in 1 CARTON (55505-192-57) / 1 BOTTLE in 1 CARTON / 200 mL in 1 BOTTLE
455505-192-592 CARTON in 1 CARTON (55505-192-59) / 325 mL in 1 CARTON

NDC Record

Field Name Field Value Definition
PRODUCT NDC55505-192The 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 OTC 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 NAMENizoralThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEKetoconazoleThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESHAMPOOThe 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 DATE1/7/2019This 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 NUMBERNDA020310This 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 NAMEKramer LaboratoriesName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEKETOCONAZOLEAn 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/mL 
PHARM CLASSESAzole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] 

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