NDC Package 71045-010-02 Zemdri (plazomicin)

Plazomicin Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
71045-010-02
Package Description:
10 VIAL in 1 CARTON / 10 mL in 1 VIAL (71045-010-01)
Product Code:
Proprietary Name:
Zemdri (plazomicin)
Non-Proprietary Name:
Plazomicin
Substance Name:
Plazomicin
Usage Information:
ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside [see Warnings and Precautions (5.5)].
11-Digit NDC Billing Format:
71045001002
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2049553 - plazomicin 500 MG in 10 ML Injection
  • RxCUI: 2049553 - 10 ML plazomicin 50 MG/ML Injection
  • RxCUI: 2049553 - plazomicin 500 MG per 10 ML Injection
  • RxCUI: 2049558 - ZEMDRI 500 MG in 10 ML Injection
  • RxCUI: 2049558 - 10 ML plazomicin 50 MG/ML Injection [Zemdri]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Achaogen, 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):
    Sample Package:
    No
    FDA Application Number:
    NDA210303
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-16-2018
    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.

    Frequently Asked Questions

    What is NDC 71045-010-02?

    The NDC Packaged Code 71045-010-02 is assigned to a package of 10 vial in 1 carton / 10 ml in 1 vial (71045-010-01) of Zemdri (plazomicin), a human prescription drug labeled by Achaogen, Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 71045-010 included in the NDC Directory?

    Yes, Zemdri (plazomicin) with product code 71045-010 is active and included in the NDC Directory. The product was first marketed by Achaogen, Inc. on July 16, 2018 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 71045-010-02?

    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 71045-010-02?

    The 11-digit format is 71045001002. 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
    5-3-271045-010-025-4-271045-0010-02