Oralone Paste
NDC Package 51672-1335-5

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

Oralone (triamcinolone acetonide) pastes 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 paste delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-1335 and is authorized under FDA application ANDA070730.

Identification & Billing

NDC Package Code
51672-1335-5
Package Description
1 TUBE in 1 CARTON / 5 g in 1 TUBE
Product Code
51672-1335
11-Digit Billing Format
51672133505
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
5 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oralone
Non-Proprietary Name
Triamcinolone Acetonide
Substance Name
Triamcinolone Acetonide
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
TRIAMCINOLONE ACETONIDE 1 mg/g
Pharmacologic Class
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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA070730
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-1986
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51672-1335). Click a package code to view its specific billing and regulatory data.

51672-1335-8
1 TUBE in 1 CARTON / 7.5 g in 1 TUBE

* 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 51672-1335-5 identifies a specific commercial package of 1 tube in 1 carton / 5 g in 1 tube of Oralone, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This paste is formulated for dental 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 Sun Pharmaceutical Industries, Inc. on October 01, 1986. 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 Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672133505. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 5 total billable units per package. 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)
51672-1335-5
11-Digit CMS (5-4-2)
51672-1335-05

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