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  5. NDC Package Code: 0173-0912-13 Zejula

NDC Package 0173-0912-13 Zejula

Niraparib Tablet, Film Coated Oral - 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:
0173-0912-13
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0173-0912
Proprietary Name:
Zejula
Non-Proprietary Name:
Niraparib
Substance Name:
Niraparib Tosylate Monohydrate
Usage Information:
Niraparib is used to treat ovarian cancer, fallopian tube cancer, or a type of cancer of the abdomen (primary peritoneal cancer). It works by slowing the growth of cancer cells.
11-Digit NDC Billing Format:
00173091213
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2637449 - niraparib 100 MG Oral Tablet
  • RxCUI: 2637449 - niraparib 100 MG (as niraparib tosylate monohydrate 159.3 MG) Oral Tablet
  • RxCUI: 2637452 - niraparib 200 MG Oral Tablet
  • RxCUI: 2637452 - niraparib 200 MG (as niraparib tosylate monohydrate 318.7 MG) Oral Tablet
  • RxCUI: 2637465 - niraparib 300 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Glaxosmithkline Llc
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • NIRAPARIB TOSYLATE MONOHYDRATE 200 mg/1
    • Pharmacologic Class(es):
  • Poly(ADP-Ribose) Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Poly(ADP-Ribose) Polymerase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA214876
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-27-2023
    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
    0173-0912-6130 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0173-0912-13?

    The NDC Packaged Code 0173-0912-13 is assigned to a package of 30 tablet, film coated in 1 bottle of Zejula, a human prescription drug labeled by Glaxosmithkline Llc. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 0173-0912 included in the NDC Directory?

    Yes, Zejula with product code 0173-0912 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Llc on June 27, 2023 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 0173-0912-13?

    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 30.

    What is the 11-digit format for NDC 0173-0912-13?

    The 11-digit format is 00173091213. 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 4-4-2 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
    4-4-20173-0912-135-4-200173-0912-13