NDC Package 67457-616-10 Gemcitabine

Gemcitabine Hydrochloride Injection, 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:
67457-616-10
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 5.26 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Gemcitabine
Non-Proprietary Name:
Gemcitabine Hydrochloride
Substance Name:
Gemcitabine Hydrochloride
Usage Information:
Gemcitabine Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1)].
11-Digit NDC Billing Format:
67457061610
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1720960 - gemcitabine 1 GM in 26.3 ML Injection
  • RxCUI: 1720960 - 26.3 ML gemcitabine 38 MG/ML Injection
  • RxCUI: 1720960 - gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML Injection
  • RxCUI: 1720960 - gemcitabine 1 GM per 26.3 ML Injection
  • RxCUI: 1720975 - gemcitabine 2 GM in 52.6 ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Institutional Llc
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    ANDA205242
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-03-2018
    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 67457-616-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    67457061610J9201In gemcitabine hcl nos 200mg200 MG5.26111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 67457-616-10?

    The NDC Packaged Code 67457-616-10 is assigned to a package of 1 vial, single-dose in 1 carton / 5.26 ml in 1 vial, single-dose of Gemcitabine, a human prescription drug labeled by Mylan Institutional Llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 67457-616 included in the NDC Directory?

    Yes, Gemcitabine with product code 67457-616 is active and included in the NDC Directory. The product was first marketed by Mylan Institutional Llc on January 03, 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 67457-616-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 67457-616-10?

    The 11-digit format is 67457061610. 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
    5-3-267457-616-105-4-267457-0616-10