Betamethasone Dipropionate Ointment, Augmented
NDC Package 35573-107-49

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

Betamethasone Dipropionate ointment is a medication used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). This formulation utilizes a ointment, augmented delivery system. Marketed by Burel Pharmaceuticals, Llc, this product is identified by NDC 35573-107 and is authorized under FDA application ANDA218289.

Identification & Billing

NDC Package Code
35573-107-49
Package Description
1 TUBE in 1 CARTON / 50 g in 1 TUBE
Product Code
35573-107
11-Digit Billing Format
35573010749
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk
  • RxCUI: 848180 - betamethasone dipropionate 0.05 % Augmented Topical Ointment
  • RxCUI: 848180 - Augmented betamethasone 0.0005 MG/MG Topical Ointment
  • RxCUI: 848180 - augmented betamethasone 0.05 % Topical Ointment
  • RxCUI: 848180 - betamethasone 0.05 % Augmented Topical Ointment
  • RxCUI: 848180 - betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical Ointment

Clinical Specifications

Proprietary Name
Betamethasone Dipropionate
Non-Proprietary Name
Betamethasone Dipropionate
Substance Name
Betamethasone Dipropionate
Dosage Form
Ointment, Augmented - An ointment dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented".
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)
BETAMETHASONE DIPROPIONATE .5 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Betamethasone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a strong corticosteroid.

Regulatory & Marketing

Labeler Name
Burel Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA218289
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-15-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (35573-107). Click a package code to view its specific billing and regulatory data.

35573-107-15
1 TUBE in 1 CARTON / 15 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 35573-107-49 identifies a specific commercial package of 1 tube in 1 carton / 50 g in 1 tube of Betamethasone Dipropionate, a human prescription drug labeled by Burel Pharmaceuticals, Llc. This ointment, augmented is formulated for topical use and contains betamethasone dipropionate 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 Burel Pharmaceuticals, Llc on January 15, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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

How is this Burel Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35573010749. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 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)
35573-107-49
11-Digit CMS (5-4-2)
35573-0107-49

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