1. Home
  2. Labeler Index
  3. Aphena Pharma Solutions - Tennessee, Llc
  4. 43353-138
  5. NDC Package Code: 43353-138-09 Calcitriol

NDC Package 43353-138-09 Calcitriol

Capsule Oral - 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:
43353-138-09
Package Description:
9000 CAPSULE in 1 BOTTLE
Product Code:
43353-138
Proprietary Name:
Calcitriol
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:
43353013809
NDC to RxNorm Crosswalk:
  • RxCUI: 308867 - calcitriol 0.25 MCG Oral Capsule
  • RxCUI: 308867 - calcitriol 0.00025 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aphena Pharma Solutions - Tennessee, Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CALCITRIOL .25 ug/1
    • Pharmacologic Class(es):
  • Cholecalciferol - [CS]
  • Vitamin D3 Analog - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA018044
    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:
    08-26-2009
    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
    43353-138-3030 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43353-138-09?

    The NDC Packaged Code 43353-138-09 is assigned to a package of 9000 capsule in 1 bottle of Calcitriol, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 43353-138 included in the NDC Directory?

    Yes, Calcitriol with product code 43353-138 is active and included in the NDC Directory. The product was first marketed by Aphena Pharma Solutions - Tennessee, Llc on August 26, 2009 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 11-digit format for NDC 43353-138-09?

    The 11-digit format is 43353013809. 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
    5-3-243353-138-095-4-243353-0138-09