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  5. NDC Package Code: 0781-7165-95 Calcipotriene And Betamethasone Dipropionate

NDC Package 0781-7165-95 Calcipotriene And Betamethasone Dipropionate

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:
0781-7165-95
Package Description:
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code:
0781-7165
Proprietary Name:
Calcipotriene And Betamethasone Dipropionate
Non-Proprietary Name:
Calcipotriene And Betamethasone Dipropionate
Substance Name:
Betamethasone Dipropionate; Calcipotriene
Usage Information:
Calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. Pediatric use information for patients ages 12 years and above is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Ointment. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.
11-Digit NDC Billing Format:
00781716595
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
100 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 388525 - calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical Ointment
  • RxCUI: 388525 - betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical Ointment
  • RxCUI: 388525 - betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical Ointment
  • RxCUI: 388525 - betamethasone 0.05 % / calcipotriene 0.005 % Topical Ointment
  • RxCUI: 388525 - betamethasone 0.5 MG (betamethasone dipropionate 0.64 MG) / calcipotriene 0.05 MG per GM Topical Ointment
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz 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):
  • BETAMETHASONE DIPROPIONATE .5 mg/g
  • CALCIPOTRIENE 50 ug/g
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Vitamin D Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin D - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA201615
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-31-2014
    End Marketing Date:
    04-30-2024
    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
    0781-7165-351 TUBE in 1 CARTON / 60 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0781-7165-95?

    The NDC Packaged Code 0781-7165-95 is assigned to a package of 1 tube in 1 carton / 100 g in 1 tube of Calcipotriene And Betamethasone Dipropionate, a human prescription drug labeled by Sandoz Inc.. The product's dosage form is ointment and is administered via topical form.

    Is NDC 0781-7165 included in the NDC Directory?

    Yes, Calcipotriene And Betamethasone Dipropionate with product code 0781-7165 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc. on March 31, 2014.

    What is the NDC billing unit for package 0781-7165-95?

    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 100.

    What is the 11-digit format for NDC 0781-7165-95?

    The 11-digit format is 00781716595. 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 4-4-2 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
    4-4-20781-7165-955-4-200781-7165-95