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  5. NDC Package Code: 68462-683-01 Sirolimus

NDC Package 68462-683-01 Sirolimus

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
68462-683-01
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
68462-683
Proprietary Name:
Sirolimus
Non-Proprietary Name:
Sirolimus
Substance Name:
Sirolimus
Usage Information:
Sirolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own. Sirolimus may also be used to treat a certain lung disease (lymphangioleiomyomatosis-LAM).
11-Digit NDC Billing Format:
68462068301
NDC to RxNorm Crosswalk:
  • RxCUI: 349208 - sirolimus 1 MG Oral Tablet
  • RxCUI: 360110 - sirolimus 2 MG Oral Tablet
  • RxCUI: 905158 - sirolimus 0.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Glenmark Pharmaceuticals Inc., Usa
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SIROLIMUS 1 mg/1
    • Pharmacologic Class(es):
  • Decreased Immunologic Activity - [PE] (Physiologic Effect)
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Protein Kinase Inhibitors - [MoA] (Mechanism of Action)
  • mTOR Inhibitor Immunosuppressant - [EPC] (Established Pharmacologic Class)
  • mTOR Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208691
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-16-2020
    Listing Expiration Date:
    12-31-2025
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 68462-683-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    68462068301J7520Sirolimus, oral1 MG1001100100

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68462-683-01?

    The NDC Packaged Code 68462-683-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Sirolimus, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 68462-683 included in the NDC Directory?

    Yes, Sirolimus with product code 68462-683 is active and included in the NDC Directory. The product was first marketed by Glenmark Pharmaceuticals Inc., Usa on October 16, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68462-683-01?

    The 11-digit format is 68462068301. 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
    5-3-268462-683-015-4-268462-0683-01