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  5. NDC Package Code: 70377-019-21 Fingolimod

NDC Package 70377-019-21 Fingolimod

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:
70377-019-21
Package Description:
28 CAPSULE in 1 CARTON
Product Code:
70377-019
Proprietary Name:
Fingolimod
Non-Proprietary Name:
Fingolimod
Substance Name:
Fingolimod Hydrochloride
Usage Information:
Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older.Pediatric use information is approved for Novartis Pharmaceuticals Corporation’s GILENYA (fingolimod) capsules. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
11-Digit NDC Billing Format:
70377001921
Product Type:
Human Prescription Drug
Labeler Name:
Biocon Pharma Inc.
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):
  • FINGOLIMOD HYDROCHLORIDE .5 mg/1
    • Pharmacologic Class(es):
  • Sphingosine 1-Phosphate Receptor Modulators - [MoA] (Mechanism of Action)
  • Sphingosine 1-phosphate Receptor Modulator - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA207979
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-28-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70377-019-1130 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70377-019-21?

    The NDC Packaged Code 70377-019-21 is assigned to a package of 28 capsule in 1 carton of Fingolimod, a human prescription drug labeled by Biocon Pharma Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 70377-019 included in the NDC Directory?

    Yes, Fingolimod with product code 70377-019 is active and included in the NDC Directory. The product was first marketed by Biocon Pharma Inc. on March 28, 2024 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 70377-019-21?

    The 11-digit format is 70377001921. 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
    5-3-270377-019-215-4-270377-0019-21