NDC Package 55111-687-25 Gemcitabine

Injection, Powder, Lyophilized, For Solution 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:
55111-687-25
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-USE
Product Code:
Proprietary Name:
Gemcitabine
Non-Proprietary Name:
Gemcitabine
Substance Name:
Gemcitabine Hydrochloride
Usage Information:
Gemcitabine for injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
11-Digit NDC Billing Format:
55111068725
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: 1719000 - gemcitabine 200 MG Injection
  • RxCUI: 1719000 - gemcitabine (as gemcitamine HCl) 200 MG Injection
  • RxCUI: 1719003 - gemcitabine 1 GM Injection
  • RxCUI: 1719003 - gemcitabine 1000 MG Injection
  • RxCUI: 1719003 - gemcitabine (as gemcitamine HCl) 1 GM Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr. Reddy's Laboratories Limited
    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.
  • Sample Package:
    No
    FDA Application Number:
    ANDA091365
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-25-2011
    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 55111-687-25?

    The NDC Packaged Code 55111-687-25 is assigned to a package of 1 vial, single-use in 1 carton / 25 ml in 1 vial, single-use of Gemcitabine, a human prescription drug labeled by Dr. Reddy's Laboratories Limited. 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 55111-687 included in the NDC Directory?

    Yes, Gemcitabine with product code 55111-687 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories Limited on July 25, 2011 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 55111-687-25?

    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 55111-687-25?

    The 11-digit format is 55111068725. 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
    5-3-255111-687-255-4-255111-0687-25