1. Home
  2. Labeler Index
  3. Ipsen Biopharmaceuticals, Inc.
  4. 15054-0043
  5. NDC Package Code: 15054-0043-1 Onivyde

NDC Package 15054-0043-1 Onivyde

Irinotecan Hydrochloride Injection, Powder, 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:
15054-0043-1
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code:
15054-0043
Proprietary Name:
Onivyde
Non-Proprietary Name:
Irinotecan Hydrochloride
Substance Name:
Irinotecan Hydrochloride
Usage Information:
Irinotecan liposomal is used to treat cancer of the pancreas.
11-Digit NDC Billing Format:
15054004301
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1719772 - irinotecan HCl liposome 43 MG in 10 ML Injection
  • RxCUI: 1719772 - 10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection
  • RxCUI: 1719772 - irinotecan hydrochloride liposome 43 MG per 10 ML Injection
  • RxCUI: 1719777 - Onivyde 43 MG in 10 ML Injection
  • RxCUI: 1719777 - 10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection [Onivyde]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ipsen Biopharmaceuticals, Inc.
    Dosage Form:
    Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • IRINOTECAN HYDROCHLORIDE 4.3 mg/mL
    • Pharmacologic Class(es):
  • Topoisomerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Topoisomerase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA207793
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-22-2015
    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.

    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 15054-0043-1 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    15054004301J9205Inj irinotecan liposome 1 mg1 MG1014343

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 15054-0043-1?

    The NDC Packaged Code 15054-0043-1 is assigned to a package of 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Onivyde, a human prescription drug labeled by Ipsen Biopharmaceuticals, Inc.. The product's dosage form is injection, powder, for solution and is administered via intravenous form.

    Is NDC 15054-0043 included in the NDC Directory?

    Yes, Onivyde with product code 15054-0043 is active and included in the NDC Directory. The product was first marketed by Ipsen Biopharmaceuticals, Inc. on October 22, 2015 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 15054-0043-1?

    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 15054-0043-1?

    The 11-digit format is 15054004301. 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 5-4-1 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
    5-4-115054-0043-15-4-215054-0043-01