NDC Package 25021-235-50 Gemcitabine

Gemcitabine Hydrochloride 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:
25021-235-50
Package Description:
1 VIAL in 1 CARTON / 25 mL in 1 VIAL
Product Code:
Proprietary Name:
Gemcitabine
Non-Proprietary Name:
Gemcitabine Hydrochloride
Substance Name:
Gemcitabine Hydrochloride
Usage Information:
Gemcitabine for Injection, USP is contraindicated in patients with a known hypersensitivity to gemcitabine.
11-Digit NDC Billing Format:
25021023550
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:
    Sagent Pharmaceuticals
    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:
    ANDA202485
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-29-2014
    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 25021-235-50 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    25021023550J9201In gemcitabine hcl nos 200mg200 MG1155

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    25021-235-5110 VIAL in 1 CARTON / 25 mL in 1 VIAL

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    Frequently Asked Questions

    What is NDC 25021-235-50?

    The NDC Packaged Code 25021-235-50 is assigned to a package of 1 vial in 1 carton / 25 ml in 1 vial of Gemcitabine, a human prescription drug labeled by Sagent Pharmaceuticals. 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 25021-235 included in the NDC Directory?

    Yes, Gemcitabine with product code 25021-235 is active and included in the NDC Directory. The product was first marketed by Sagent Pharmaceuticals on December 29, 2014 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 25021-235-50?

    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 25021-235-50?

    The 11-digit format is 25021023550. 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
    5-3-225021-235-505-4-225021-0235-50