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  5. NDC Package Code: 71715-001-02 Nuzyra

NDC Package 71715-001-02 Nuzyra

Omadacycline Injection, Powder, Lyophilized, For Solution Intravenous - 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:
71715-001-02
Package Description:
10 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS (71715-001-01)
Product Code:
71715-001
Proprietary Name:
Nuzyra
Non-Proprietary Name:
Omadacycline
Substance Name:
Omadacycline
Usage Information:
Omadacycline is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
11-Digit NDC Billing Format:
71715000102
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2059274 - omadacycline 150 MG Oral Tablet
  • RxCUI: 2059280 - NUZYRA 150 MG Oral Tablet
  • RxCUI: 2059280 - omadacycline 150 MG Oral Tablet [Nuzyra]
  • RxCUI: 2059280 - Nuzyra 150 MG Oral Tablet
  • RxCUI: 2059281 - {14 (omadacycline 150 MG Oral Tablet) } Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Paratek Pharmaceuticals, Inc.
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • OMADACYCLINE 100 mg/5mL
    • Pharmacologic Class(es):
  • Tetracycline-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Tetracyclines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA209817
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-01-2019
    Listing Expiration Date:
    12-31-2024
    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 71715-001-02 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    71715000102J0121Inj., omadacycline, 1 mg1 MG1101001000

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71715-001-02?

    The NDC Packaged Code 71715-001-02 is assigned to a package of 10 vial, glass in 1 carton / 10 ml in 1 vial, glass (71715-001-01) of Nuzyra, a human prescription drug labeled by Paratek Pharmaceuticals, Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 71715-001 included in the NDC Directory?

    Yes, Nuzyra with product code 71715-001 is active and included in the NDC Directory. The product was first marketed by Paratek Pharmaceuticals, Inc. on February 01, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 71715-001-02?

    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 1.

    What is the 11-digit format for NDC 71715-001-02?

    The 11-digit format is 71715000102. 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
    5-3-271715-001-025-4-271715-0001-02