Diflorasone Diacetate Ointment
NDC Package 64980-124-45

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

Diflorasone Diacetate ointment is diflorasone is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). This formulation utilizes a ointment delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 64980-124 and is authorized under FDA application ANDA207440.

Identification & Billing

NDC Package Code
64980-124-45
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
64980-124
11-Digit Billing Format
64980012445
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diflorasone Diacetate
Non-Proprietary Name
Diflorasone Diacetate
Substance Name
Diflorasone Diacetate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
DIFLORASONE DIACETATE .5 mg/g
Pharmacologic Class
Usage Information
Diflorasone is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Diflorasone reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a strong (high-potency) corticosteroid.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207440
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-27-2017
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 (64980-124). Click a package code to view its specific billing and regulatory data.

64980-124-03
1 TUBE in 1 CARTON / 30 g in 1 TUBE
64980-124-15
1 TUBE in 1 CARTON / 15 g in 1 TUBE
64980-124-60
1 TUBE in 1 CARTON / 60 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 64980-124-45 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Diflorasone Diacetate, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This ointment is formulated for topical use and contains diflorasone diacetate 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 Rising Pharma Holdings, Inc. on February 27, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Diflorasone is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Diflorasone reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a strong (high-potency) corticosteroid.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64980012445. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 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 (5-3-2)
64980-124-45
11-Digit CMS (5-4-2)
64980-0124-45

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