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  5. NDC Package Code: 43386-096-61 Clobetasol Propionate

NDC Package 43386-096-61 Clobetasol Propionate

Ointment Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43386-096-61
Package Description:
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code:
43386-096
Proprietary Name:
Clobetasol Propionate
Non-Proprietary Name:
Clobetasol Propionate
Substance Name:
Clobetasol Propionate
Usage Information:
This medication is used to treat a variety of skin conditions (e.g., eczema, psoriasis, dermatitis, allergies, rash). Clobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a very strong (super-high-potency) corticosteroid.
11-Digit NDC Billing Format:
43386009661
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
30 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 861448 - clobetasol propionate 0.05 % Topical Ointment
  • RxCUI: 861448 - clobetasol propionate 0.0005 MG/MG Topical Ointment
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals,inc.
    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(s):
  • 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):
  • CLOBETASOL PROPIONATE .5 mg/g
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208841
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-02-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43386-096-601 TUBE in 1 CARTON / 15 g in 1 TUBE
    43386-096-621 TUBE in 1 CARTON / 60 g in 1 TUBE
    43386-096-631 TUBE in 1 CARTON / 45 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43386-096-61?

    The NDC Packaged Code 43386-096-61 is assigned to a package of 1 tube in 1 carton / 30 g in 1 tube of Clobetasol Propionate, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. The product's dosage form is ointment and is administered via topical form.

    Is NDC 43386-096 included in the NDC Directory?

    Yes, Clobetasol Propionate with product code 43386-096 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals,inc. on June 02, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43386-096-61?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 43386-096-61?

    The 11-digit format is 43386009661. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243386-096-615-4-243386-0096-61