Triamcinolone Acetonide Spray, Metered
NDC Package 67438-045-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Triamcinolone Acetonide sprays is a medication used in a variety of conditions such as allergic disorders, arthritis, gout, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, collagen and skin diseases. This formulation utilizes a spray, metered delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 67438-045.

Identification & Billing

NDC Package Code
67438-045-01
Package Description
60 SPRAY, METERED in 1 BOTTLE
Product Code
67438-045
11-Digit Billing Format
67438004501

Clinical Specifications

Proprietary Name
Triamcinolone Acetonide
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.
Active Ingredient(s)
TRIAMCINOLONE ACETONIDE 55 ug/1
Usage Information
This medication is used in a variety of conditions such as allergic disorders, arthritis, gout, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, collagen and skin diseases. Talk to your doctor about the risks and benefits of triamcinolone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use. Triamcinolone is known as a corticosteroid hormone (glucocorticoid). It works by decreasing your body's immune response to these diseases and reduces symptoms such as swelling.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-19-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67438-045). Click a package code to view its specific billing and regulatory data.

67438-045-00
120 SPRAY, METERED in 1 BOTTLE
67438-045-02
72 SPRAY, METERED in 1 BOTTLE
67438-045-03
144 SPRAY, METERED in 1 BOTTLE

* 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 67438-045-01 identifies a specific commercial package of 60 spray, metered in 1 bottle of Triamcinolone Acetonide (UNFINISHED drug), drug for further processing labeled by Padagis Israel Pharmaceuticals Ltd. This spray, metered is formulated for 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 June 19, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used in a variety of conditions such as allergic disorders, arthritis, gout, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, collagen and skin diseases. Talk to your doctor about the risks and benefits of triamcinolone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use. Triamcinolone is known as a corticosteroid hormone (glucocorticoid). It works by decreasing your body's immune response to these diseases and reduces symptoms such as swelling.

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: 67438004501. 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)
67438-045-01
11-Digit CMS (5-4-2)
67438-0045-01

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