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  5. NDC Package Code: 65162-155-25 Cinacalcet Hydrochloride

NDC Package 65162-155-25 Cinacalcet Hydrochloride

Cinacalcet Tablet 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:
65162-155-25
Package Description:
250 TABLET in 1 BOTTLE
Product Code:
65162-155
Proprietary Name:
Cinacalcet Hydrochloride
Non-Proprietary Name:
Cinacalcet
Substance Name:
Cinacalcet Hydrochloride
Usage Information:
Cinacalcet HCl treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions (5.1)].
11-Digit NDC Billing Format:
65162015525
NDC to RxNorm Crosswalk:
  • RxCUI: 432400 - cinacalcet HCl 90 MG Oral Tablet
  • RxCUI: 432400 - cinacalcet 90 MG Oral Tablet
  • RxCUI: 432400 - cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral Tablet
  • RxCUI: 432401 - cinacalcet HCl 60 MG Oral Tablet
  • RxCUI: 432401 - cinacalcet 60 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CINACALCET HYDROCHLORIDE 30 mg/1
    • Pharmacologic Class(es):
  • Calcium-sensing Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Increased Calcium-sensing Receptor Sensitivity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA204364
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-06-2021
    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
    65162-155-0330 TABLET in 1 BOTTLE
    65162-155-10100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65162-155-25?

    The NDC Packaged Code 65162-155-25 is assigned to a package of 250 tablet in 1 bottle of Cinacalcet Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65162-155 included in the NDC Directory?

    Yes, Cinacalcet Hydrochloride with product code 65162-155 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on December 06, 2021 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 65162-155-25?

    The 11-digit format is 65162015525. 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
    5-3-265162-155-255-4-265162-0155-25