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  5. NDC Package Code: 16714-909-01 Gemcitabine

NDC Package 16714-909-01 Gemcitabine

Gemcitabine Hydrochloride Injection, Powder, Lyophilized, 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:
16714-909-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code:
16714-909
Proprietary Name:
Gemcitabine
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:
16714090901
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:
    Northstar Rx 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):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • GEMCITABINE HYDROCHLORIDE 200 mg/1
    • Pharmacologic Class(es):
  • Nucleic Acid Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Nucleoside Metabolic Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA091365
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-01-2018
    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.

    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 16714-909-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    16714090901J9201In gemcitabine hcl nos 200mg200 MG1111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 16714-909-01?

    The NDC Packaged Code 16714-909-01 is assigned to a package of 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose of Gemcitabine, a human prescription drug labeled by Northstar Rx Llc. 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 16714-909 included in the NDC Directory?

    Yes, Gemcitabine with product code 16714-909 is active and included in the NDC Directory. The product was first marketed by Northstar Rx Llc on November 01, 2018 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 16714-909-01?

    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 16714-909-01?

    The 11-digit format is 16714090901. 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
    5-3-216714-909-015-4-216714-0909-01