61748-425 NDC - NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)

Drug Information

Product NDC: 61748-425

Proprietary Name: NYSTATIN AND TRIAMCINOLONE ACETONIDE

Non Proprietary Name: nystatin and triamcinolone acetonide

Active Ingredient(s):
  • 100000 [USP'U]/g NYSTATIN;
  • 1 mg/g TRIAMCINOLONE ACETONIDE


Administration Route(s): TOPICAL

Dosage Form(s): OINTMENT

Pharmacy Class(es):
  • Polyene Antifungal [EPC];
  • Polyenes [CS];
  • Corticosteroid [EPC];
  • Corticosteroid Hormone Receptor Agonists [MoA]

Labeler Information

Labeler Name: Versapharm Incorporated
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA207217
Marketing Category: ANDA
Start Marketing Date:9/1/2017

Package Information

No. Package Code Package Description Billing Unit
161748-425-151 TUBE in 1 CARTON (61748-425-15) > 15 g in 1 TUBE
261748-425-301 TUBE in 1 CARTON (61748-425-30) > 30 g in 1 TUBE
361748-425-601 TUBE in 1 CARTON (61748-425-60) > 60 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC61748-425The 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 NAMENYSTATIN AND TRIAMCINOLONE ACETONIDEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEnystatin and triamcinolone acetonideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEOINTMENTThe 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 DATE9/1/2017This 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 NUMBERANDA207217This 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 NAMEVersapharm IncorporatedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMENYSTATIN; TRIAMCINOLONE ACETONIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH100000; 1 
ACTIVE INGRED UNIT[USP'U]/g; mg/g 
PHARM CLASSESPolyene Antifungal [EPC],Polyenes [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 

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This page was last updated on: 6/1/2021