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  5. NDC Package Code: 68308-665-10 Calcitrol

NDC Package 68308-665-10 Calcitrol

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

Table of Contents

    1. Package Information
    2. 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:
68308-665-10
Package Description:
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code:
68308-665
Proprietary Name:
Calcitrol
Non-Proprietary Name:
Calcitriol
Substance Name:
Calcitriol
Usage Information:
Calcitriol is a man-made active form of vitamin D. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones. Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Calcitriol is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol is usually used along with specific diet recommendations and sometimes other medications.
11-Digit NDC Billing Format:
68308066510
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: 388517 - calcitriol 0.0003 % Topical Ointment
  • RxCUI: 388517 - calcitriol 0.000003 MG/MG Topical Ointment
  • RxCUI: 388517 - calcitriol 3 MCG/GM Topical Ointment
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mayne Pharma Commercial Llc.
    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):
  • CALCITRIOL 3 ug/g
    • Pharmacologic Class(es):
  • Cholecalciferol - [CS]
  • Vitamin D3 Analog - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA022087
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    07-21-2023
    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.

    Frequently Asked Questions

    What is NDC 68308-665-10?

    The NDC Packaged Code 68308-665-10 is assigned to a package of 1 tube in 1 carton / 100 g in 1 tube of Calcitrol, a human prescription drug labeled by Mayne Pharma Commercial Llc.. The product's dosage form is ointment and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 100 billable units per package.

    Is NDC 68308-665 included in the NDC Directory?

    Yes, Calcitrol with product code 68308-665 is active and included in the NDC Directory. The product was first marketed by Mayne Pharma Commercial Llc. on July 21, 2023 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 68308-665-10?

    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 68308-665-10?

    The 11-digit format is 68308066510. 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
    5-3-268308-665-105-4-268308-0665-10