Triamcinolone Acetonide Spray, Metered
NDC Package 12516-1510-0

11-digit billing NDC: 12516151000
Table of Contents
    1. Package Information
    2. 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 drug for further processing. This formulation utilizes a spray, metered delivery system. Marketed by Bespak Hc Limited, this product is identified by NDC 12516-1510.

Identification & Billing

NDC Package Code
12516-1510-0
Package Description
189 BOTTLE, SPRAY in 1 CARTON / 6.5 g in 1 BOTTLE, SPRAY
Product Code
12516-1510
11-Digit Billing Format
12516151000

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 mg/g

Regulatory & Marketing

Labeler Name
Bespak Hc Limited
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
09-07-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 12516-1510-0 identifies a specific commercial package of 189 bottle, spray in 1 carton / 6.5 g in 1 bottle, spray of Triamcinolone Acetonide (UNFINISHED drug), drug for further processing labeled by Bespak Hc Limited. 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 Bespak Hc Limited on September 07, 2017. The current certification is valid through December 31, 2026.

How is this Bespak Hc Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12516151000. 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 (5-4-1)
12516-1510-0
11-Digit CMS (5-4-2)
12516-1510-00

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