Betamethasone Dipropionate Lotion
NDC Package 45802-021-46

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

Package Information

Betamethasone Dipropionate lotions is a medication used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). This formulation utilizes a lotion delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-021 and is authorized under FDA application ANDA072538.

Identification & Billing

NDC Package Code
45802-021-46
Package Description
56.2 g in 1 BOTTLE, PLASTIC
Product Code
45802-021
11-Digit Billing Format
45802002146
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 240209 - betamethasone dipropionate 0.05 % Topical Lotion
  • RxCUI: 240209 - betamethasone 0.5 MG/ML Topical Lotion
  • RxCUI: 240209 - betamethasone 0.05 % Topical Lotion
  • RxCUI: 240209 - betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) Topical Lotion

Clinical Specifications

Proprietary Name
Betamethasone Dipropionate
Non-Proprietary Name
Betamethasone Dipropionate
Substance Name
Betamethasone Dipropionate
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA072538
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2006
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 45802-021-46 identifies a specific commercial package of 56.2 g in 1 bottle, plastic of Betamethasone Dipropionate, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This lotion 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 Padagis Israel Pharmaceuticals Ltd on June 30, 2006. 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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802002146. 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 (5-3-2)
45802-021-46
11-Digit CMS (5-4-2)
45802-0021-46

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