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  5. NDC Package Code: 82919-626-16 Ontralfy

NDC Package 82919-626-16 Ontralfy

Tizanidine Hydrochloride Solution 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:
82919-626-16
Package Description:
473 mL in 1 BOTTLE, PLASTIC
Product Code:
82919-626
Proprietary Name:
Ontralfy
Non-Proprietary Name:
Tizanidine Hydrochloride
Substance Name:
Tizanidine Hydrochloride
Usage Information:
Ontralfy is indicated for the treatment of spasticity in adults.
11-Digit NDC Billing Format:
82919062616
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Fidelity Biopharma Co.
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
TIZANIDINE HYDROCHLORIDE 2 mg/5mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA216190
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
03-31-2025
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 82919-626-16?

The NDC Packaged Code 82919-626-16 is assigned to a package of 473 ml in 1 bottle, plastic of Ontralfy, a human prescription drug labeled by Fidelity Biopharma Co.. The product's dosage form is solution and is administered via oral form.

Is NDC 82919-626 included in the NDC Directory?

Yes, Ontralfy with product code 82919-626 is active and included in the NDC Directory. The product was first marketed by Fidelity Biopharma Co. on March 31, 2025 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 82919-626-16?

The 11-digit format is 82919062616. 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
5-3-282919-626-165-4-282919-0626-16