Deflazacort Oral Suspension
NDC Package 70710-2007-3

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

Package Information

Deflazacort Oral Suspension (deflazacort) suspension is deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza™ (deflazacort) oral suspension. This formulation utilizes a suspension delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 70710-2007 and is authorized under FDA application ANDA220042.

Identification & Billing

NDC Package Code
70710-2007-3
Package Description
1 BOTTLE in 1 CARTON / 13 mL in 1 BOTTLE
Product Code
70710-2007
11-Digit Billing Format
70710200703
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Deflazacort Oral Suspension
Non-Proprietary Name
Deflazacort
Substance Name
Deflazacort
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEFLAZACORT 22.75 mg/mL
Pharmacologic Class
Usage Information
Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza™ (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA220042
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-23-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70710-2007-3 identifies a specific commercial package of 1 bottle in 1 carton / 13 ml in 1 bottle of Deflazacort Oral Suspension, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This suspension 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 Zydus Pharmaceuticals (usa) Inc. on October 23, 2025. The current certification is valid through December 31, 2026.

How is this Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710200703. 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 (5-4-1)
70710-2007-3
11-Digit CMS (5-4-2)
70710-2007-03

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