NDC Package 67457-528-10 Leucovorin Calcium

Injection, Powder, Lyophilized, For Suspension Intramuscular; 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:
67457-528-10
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Leucovorin Calcium
Non-Proprietary Name:
Leucovorin Calcium
Substance Name:
Leucovorin Calcium
Usage Information:
This medication is used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). It may also be used with a certain cancer drug (5-fluorouracil) to treat patients with colon cancer. Leucovorin may also be used to treat a certain type of anemia (due to folic acid deficiency) when folic acid cannot be taken by mouth.
11-Digit NDC Billing Format:
67457052810
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: 1803932 - leucovorin 100 MG Injection
  • RxCUI: 1803932 - leucovorin (as leucovorin calcium) 100 MG Injection
  • RxCUI: 1803937 - leucovorin 200 MG Injection
  • RxCUI: 1803937 - leucovorin (as leucovorin calcium) 200 MG Injection
  • RxCUI: 237788 - leucovorin 350 MG Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Institutional Llc
    Dosage Form:
    Injection, Powder, Lyophilized, For Suspension - A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA203800
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-23-2019
    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 67457-528-10?

    The NDC Packaged Code 67457-528-10 is assigned to a package of 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Leucovorin Calcium, a human prescription drug labeled by Mylan Institutional Llc. The product's dosage form is injection, powder, lyophilized, for suspension and is administered via intramuscular; intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 67457-528 included in the NDC Directory?

    Yes, Leucovorin Calcium with product code 67457-528 is active and included in the NDC Directory. The product was first marketed by Mylan Institutional Llc on July 23, 2019 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 67457-528-10?

    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 67457-528-10?

    The 11-digit format is 67457052810. 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
    5-3-267457-528-105-4-267457-0528-10