69842-765 NDC - FLUTICASONE PROPIONATE

Drug Information

Product NDC: 69842-765

Proprietary Name: Fluticasone Propionate

Non Proprietary Name: Fluticasone Propionate

Active Ingredient(s):
  • 50 ug/1 FLUTICASONE PROPIONATE


Administration Route(s): NASAL

Dosage Form(s): SPRAY, METERED

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

Labeler Information

Labeler Name: CVS Pharmacy
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA208150
Marketing Category: ANDA
Start Marketing Date:9/12/2019

Package Information

No. Package Code Package Description Billing Unit
169842-765-011 BOTTLE, SPRAY in 1 CARTON (69842-765-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
269842-765-022 BOTTLE, SPRAY in 1 CARTON (69842-765-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
369842-765-033 BOTTLE, SPRAY in 1 CARTON (69842-765-03) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
469842-765-041 BOTTLE, SPRAY in 1 CARTON (69842-765-04) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY

NDC Record

Field Name Field Value Definition
PRODUCT NDC69842-765The 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 NAMEFluticasone PropionateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEFluticasone PropionateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAY, METEREDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMENASALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/12/2019This 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 NUMBERANDA208150This 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 NAMECVS PharmacyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEFLUTICASONE PROPIONATEAn 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 STRENGTH50 
ACTIVE INGRED UNITug/1 
PHARM CLASSESCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] 

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