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  5. NDC Package Code: 63459-177-14 Synribo

NDC Package 63459-177-14 Synribo

Omacetaxine Mepesuccinate Injection, Powder, Lyophilized, For Solution Subcutaneous - 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:
63459-177-14
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE
Product Code:
63459-177
Proprietary Name:
Synribo
Non-Proprietary Name:
Omacetaxine Mepesuccinate
Substance Name:
Omacetaxine Mepesuccinate
Usage Information:
This medication is used to treat a certain type of cancer (chronic myeloid leukemia-CML). It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
63459017714
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: 1356688 - omacetaxine mepesuccinate 3.5 MG Injection
  • RxCUI: 1356693 - Synribo 3.5 MG Injection
  • RxCUI: 1356693 - omacetaxine mepesuccinate 3.5 MG Injection [Synribo]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Cephalon, Llc
    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):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • OMACETAXINE MEPESUCCINATE 3.5 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    NDA203585
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-19-2012
    End Marketing Date:
    04-30-2024
    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 63459-177-14 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    63459017714J9262Inj, omacetaxine mep, 0.01mg0.01 mg11350350

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63459-177-14?

    The NDC Packaged Code 63459-177-14 is assigned to a package of 1 vial, single-use in 1 carton / 1 ml in 1 vial, single-use of Synribo, a human prescription drug labeled by Cephalon, Llc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via subcutaneous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 63459-177 included in the NDC Directory?

    Yes, Synribo with product code 63459-177 is active and included in the NDC Directory. The product was first marketed by Cephalon, Llc on November 19, 2012.

    What is the NDC billing unit for package 63459-177-14?

    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 63459-177-14?

    The 11-digit format is 63459017714. 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
    5-3-263459-177-145-4-263459-0177-14