0135-0576 NDC - FLONASE (FLUTICASONE PROPIONATE)

Drug Information

Product NDC: 0135-0576

Proprietary Name: FLONASE

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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: NDA205434
Marketing Category: NDA
Start Marketing Date:12/4/2014

Package Information

No. Package Code Package Description Billing Unit
10135-0576-011 BOTTLE in 1 CARTON (0135-0576-01) / 30 SPRAY, METERED in 1 BOTTLE
20135-0576-021 BOTTLE in 1 PACKAGE (0135-0576-02) / 60 SPRAY, METERED in 1 BOTTLEML
30135-0576-031 BOTTLE in 1 PACKAGE (0135-0576-03) / 120 SPRAY, METERED in 1 BOTTLEML
40135-0576-043 BOTTLE in 1 PACKAGE (0135-0576-04) / 120 SPRAY, METERED in 1 BOTTLEML
50135-0576-122 BOTTLE in 1 PACKAGE (0135-0576-12) / 120 SPRAY, METERED in 1 BOTTLE
60135-0576-141 BOTTLE in 1 PACKAGE (0135-0576-14) / 144 SPRAY, METERED in 1 BOTTLEML
70135-0576-152 BOTTLE in 1 PACKAGE (0135-0576-15) / 144 SPRAY, METERED in 1 BOTTLEML
80135-0576-163 BOTTLE in 1 PACKAGE (0135-0576-16) / 144 SPRAY, METERED in 1 BOTTLEML
90135-0576-171 BOTTLE in 1 PACKAGE (0135-0576-17) / 72 SPRAY, METERED in 1 BOTTLEML
100135-0576-181 BOTTLE in 1 PACKAGE (0135-0576-18) / 90 SPRAY, METERED in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC0135-0576The 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 NAMEFLONASEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXALLERGY RELIEFA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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 DATE12/4/2014This 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 NUMBERNDA205434This 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 NAMEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCName 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