0093-3609 NDC - FLUTICASONE PROPIONATE AND SALMETEROL

Drug Information

Product NDC: 0093-3609

Proprietary Name: Fluticasone Propionate and Salmeterol

Non Proprietary Name: Fluticasone Propionate and Salmeterol

Active Ingredient(s):
  • 232 ug/1 FLUTICASONE PROPIONATE;
  • 14 ug/1 SALMETEROL XINAFOATE


Administration Route(s): RESPIRATORY (INHALATION)

Dosage Form(s): POWDER, METERED

Pharmacy Class(es):
  • Corticosteroid [EPC];
  • Corticosteroid Hormone Receptor Agonists [MoA];
  • Adrenergic beta2-Agonists [MoA];
  • beta2-Adrenergic Agonist [EPC]

Labeler Information

Labeler Name: Teva Pharmaceuticals USA, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA208799
Marketing Category: NDA AUTHORIZED GENERIC
Start Marketing Date:4/28/2017

Package Information

No. Package Code Package Description Billing Unit
10093-3609-821 POUCH in 1 CARTON (0093-3609-82) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALEREA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0093-3609The 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 NAMEFluticasone Propionate and SalmeterolThe 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 Propionate and SalmeterolThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDER, METEREDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMERESPIRATORY (INHALATION)The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/28/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDA AUTHORIZED GENERICProduct 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 NUMBERNDA208799This 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 NAMETeva Pharmaceuticals USA, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH232; 14 
ACTIVE INGRED UNITug/1; ug/1 
PHARM CLASSESCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 

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This page was last updated on: 5/17/2019