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  5. NDC Package Code: 68083-148-01 Gemcitabine Hydrochloride

NDC Package 68083-148-01 Gemcitabine Hydrochloride

Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
68083-148-01
Package Description:
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code:
68083-148
Proprietary Name:
Gemcitabine Hydrochloride
Non-Proprietary Name:
Gemcitabine Hydrochloride
Substance Name:
Gemcitabine Hydrochloride
Usage Information:
Gemcitabine for Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1)].
11-Digit NDC Billing Format:
68083014801
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:
    Gland Pharma 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.
    • Active Ingredient(s):
  • GEMCITABINE HYDROCHLORIDE 200 mg/5mL
    • Pharmacologic Class(es):
  • Nucleic Acid Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Nucleoside Metabolic Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA204520
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-01-2016
    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 68083-148-01?

    The NDC Packaged Code 68083-148-01 is assigned to a package of 1 vial in 1 carton / 5 ml in 1 vial of Gemcitabine Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 68083-148 included in the NDC Directory?

    Yes, Gemcitabine Hydrochloride with product code 68083-148 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on February 01, 2016 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 11-digit format for NDC 68083-148-01?

    The 11-digit format is 68083014801. 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
    5-3-268083-148-015-4-268083-0148-01