1. Home
  2. Labeler Index
  3. Accord Healthcare Inc.
  4. 16729-342
  5. NDC Package Code: 16729-342-10 Fingolimod Hydrochloride

NDC Package 16729-342-10 Fingolimod Hydrochloride

Capsule Oral - 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:
16729-342-10
Package Description:
30 CAPSULE in 1 BOTTLE
Product Code:
16729-342
Proprietary Name:
Fingolimod Hydrochloride
Non-Proprietary Name:
Fingolimod Hydrochloride
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:
16729034210
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Accord Healthcare 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):
Sample Package:
No
FDA Application Number:
ANDA207991
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-18-2022
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.

Frequently Asked Questions

What is NDC 16729-342-10?

The NDC Packaged Code 16729-342-10 is assigned to a package of 30 capsule in 1 bottle of Fingolimod Hydrochloride, a human prescription drug labeled by Accord Healthcare Inc.. The product's dosage form is capsule and is administered via oral form.

Is NDC 16729-342 included in the NDC Directory?

Yes, Fingolimod Hydrochloride with product code 16729-342 is active and included in the NDC Directory. The product was first marketed by Accord Healthcare Inc. on October 18, 2022 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 NDC billing unit for package 16729-342-10?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 16729-342-10?

The 11-digit format is 16729034210. 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
5-3-216729-342-105-4-216729-0342-10