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  5. NDC Package Code: 73650-316-14 Tzield

NDC Package 73650-316-14 Tzield

Teplizumab-mzwv Injection Intravenous - 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:
73650-316-14
Package Description:
14 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code:
73650-316
Proprietary Name:
Tzield
Non-Proprietary Name:
Teplizumab-mzwv
Substance Name:
Teplizumab
Usage Information:
TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes [see Dosage and Administration (2.1)].
11-Digit NDC Billing Format:
73650031614
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2621885 - teplizumab-mzwv 2 MG in 2 ML Injection
  • RxCUI: 2621885 - 2 ML teplizumab-mzwv 1 MG/ML Injection
  • RxCUI: 2621885 - teplizumab-mzwv 2 MG per 2 ML Injection
  • RxCUI: 2621891 - Tzield 2 MG in 2 ML Injection
  • RxCUI: 2621891 - 2 ML teplizumab-mzwv 1 MG/ML Injection [Tzield]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Provention Bio, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TEPLIZUMAB 1 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    BLA761183
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-17-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    73650-316-011 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
    73650-316-1010 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 73650-316-14?

    The NDC Packaged Code 73650-316-14 is assigned to a package of 14 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose of Tzield, a human prescription drug labeled by Provention Bio, Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 73650-316 included in the NDC Directory?

    Yes, Tzield with product code 73650-316 is active and included in the NDC Directory. The product was first marketed by Provention Bio, Inc. on November 17, 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 73650-316-14?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 73650-316-14?

    The 11-digit format is 73650031614. 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
    5-3-273650-316-145-4-273650-0316-14