NDC 0135-0615-01 Flonase Sensimist Allergy Relief

Fluticasone Furoate

NDC Package Code 0135-0615-01

The NDC Code 0135-0615-01 is assigned to a package of 1 bottle in 1 carton > 30 spray, metered in 1 bottle of Flonase Sensimist Allergy Relief, a human over the counter drug labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The product's dosage form is spray, metered and is administered via nasal form.

Field Name Field Value
NDC Code 0135-0615-01
Package Description 1 BOTTLE in 1 CARTON > 30 SPRAY, METERED in 1 BOTTLE
Proprietary Name Flonase Sensimist Allergy Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Fluticasone Furoate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses Fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
11-Digit NDC Billing Format 00135061501 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
RxNorm Crosswalk1797890 and 1869712 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Otc Drug What kind of product is this?
Indicates 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.
Labeler Name Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Dosage Form Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route(s)
  • Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
  • FLUTICASONE FUROATE 27.5 ug/1
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product 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.
FDA Application Number NDA022051 What is the FDA Application Number?
This 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.
Start Marketing Date 02-01-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 0135 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc
    • 0135-0615 - Flonase Sensimist
      • 0135-0615-01 - 1 BOTTLE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Flonase Sensimist with product NDC 0135-0615.

NDC Package CodePackage Description
0135-0615-021 BOTTLE in 1 PACKAGE > 60 SPRAY, METERED in 1 BOTTLE
0135-0615-031 BOTTLE in 1 PACKAGE > 120 SPRAY, METERED in 1 BOTTLE
0135-0615-043 BOTTLE in 1 PACKAGE > 120 SPRAY, METERED in 1 BOTTLE
0135-0615-052 BOTTLE in 1 PACKAGE > 120 SPRAY, METERED in 1 BOTTLE
0135-0615-061 BOTTLE in 1 PACKAGE > 72 SPRAY, METERED in 1 BOTTLE

* Please review the disclaimer below.