Triamcinolone Acetonide Nasal Spray, Metered
NDC Package 45802-109-01

11-digit billing NDC: 45802010901 · Billing unit: ML
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Triamcinolone Acetonide Nasal (triamcinolone acetonide) sprays is read insert (inside package) on how to:•get a new bottle ready (primed) before first use•prime bottle again if not used for more than 2 weeks•use the spray •clean the spray nozzleADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERadults and children12 years of ageand older•once daily, spray 2 times into each nostril while sniffing gently•once your allergy symptoms improve, reduce to 1 spray in each nostril per dayCHILDREN 2 TO UNDER 12 YEARS OF AGE•the growth rate of some children may be slower while using this product. This formulation utilizes a spray, metered delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-109 and is authorized under FDA application ANDA078104.

Identification & Billing

NDC Package Code
45802-109-01
Package Description
1 BOTTLE in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE
Product Code
45802-109
11-Digit Billing Format
45802010901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1797913 - triamcinolone acetonide 55 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797913 - triamcinolone acetonide 0.055 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Triamcinolone Acetonide Nasal
Non-Proprietary Name
Triamcinolone Acetonide
Substance Name
Triamcinolone Acetonide
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
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
TRIAMCINOLONE ACETONIDE 55 ug/1
Pharmacologic Class
Usage Information
Read insert (inside package) on how to:•get a new bottle ready (primed) before first use•prime bottle again if not used for more than 2 weeks•use the spray •clean the spray nozzleADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERadults and children12 years of ageand older•once daily, spray 2 times into each nostril while sniffing gently•once your allergy symptoms improve, reduce to 1 spray in each nostril per dayCHILDREN 2 TO UNDER 12 YEARS OF AGE•the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.children 6 to under12 years of age•an adult should supervise use•once daily, spray 1 time into each nostril while sniffing gently•if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day.children 2 to under 6 years of age•an adult should supervise use•once daily, spray 1 time into each nostril while sniffing gentlychildren under 2 years of age•do not use•do not use more than directed•if you forget a dose, do not double the next dose•do not spray into eyes or mouth•if allergy symptoms do not improve after one week, stop using and talk to a doctor•do not use for the common cold•shake well before each use

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Otc Drug
FDA Application #
ANDA078104
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-28-2017
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45802-109-01 identifies a specific commercial package of 1 bottle in 1 carton / 120 spray, metered in 1 bottle of Triamcinolone Acetonide Nasal, a human over the counter drug labeled by Padagis Israel Pharmaceuticals Ltd. This spray, metered is formulated for nasal use and contains triamcinolone acetonide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Padagis Israel Pharmaceuticals Ltd on March 28, 2017. The current certification is valid through December 31, 2027.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802010901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
45802-109-01
11-Digit CMS (5-4-2)
45802-0109-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.