Deflazacort Tablet
NDC Package 81806-204-10

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

Package Information

Deflazacort tablets is  Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. This formulation utilizes a tablet delivery system. Marketed by Doppel Farmaceutici S.r.l., this product is identified by NDC 81806-204 and is authorized under FDA application ANDA219254.

Identification & Billing

NDC Package Code
81806-204-10
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
81806-204
11-Digit Billing Format
81806020410

Clinical Specifications

Proprietary Name
Deflazacort
Non-Proprietary Name
Deflazacort
Substance Name
Deflazacort
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEFLAZACORT 6 mg/1
Pharmacologic Class
Usage Information
 Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Regulatory & Marketing

Labeler Name
Doppel Farmaceutici S.r.l.
Product Type
Human Prescription Drug
FDA Application #
ANDA219254
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2025
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 81806-204-10 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Deflazacort, a human prescription drug labeled by Doppel Farmaceutici S.r.l.. This tablet is formulated for oral use and contains deflazacort 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 Doppel Farmaceutici S.r.l. on June 12, 2025. The current certification is valid through December 31, 2027.

How is this Doppel Farmaceutici S.r.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81806020410. 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)
81806-204-10
11-Digit CMS (5-4-2)
81806-0204-10

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