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  5. NDC Package Code: 70710-1478-1 Fomepizole

NDC Package 70710-1478-1 Fomepizole

Injection, 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:
70710-1478-1
Package Description:
1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL
Product Code:
70710-1478
Proprietary Name:
Fomepizole
Non-Proprietary Name:
Fomepizole
Substance Name:
Fomepizole
Usage Information:
Fomepizole is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (see DOSAGE AND ADMINISTRATION).
11-Digit NDC Billing Format:
70710147801
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 310414 - fomepizole 1.5 GM in 1.5 ML Injection
  • RxCUI: 310414 - 1.5 ML fomepizole 1000 MG/ML Injection
  • RxCUI: 310414 - fomepizole 1.5 GM per 1.5 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Pharmaceuticals Usa Inc.
    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.
    • Active Ingredient(s):
  • FOMEPIZOLE 1 g/mL
    • Pharmacologic Class(es):
  • Antidote - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078537
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-18-2021
    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 70710-1478-1 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    70710147801J1451Fomepizole, 15 mg15 MG1.51100100

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70710-1478-1?

    The NDC Packaged Code 70710-1478-1 is assigned to a package of 1 vial in 1 carton / 1.5 ml in 1 vial of Fomepizole, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 70710-1478 included in the NDC Directory?

    Yes, Fomepizole with product code 70710-1478 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on March 18, 2021 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 70710-1478-1?

    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 70710-1478-1?

    The 11-digit format is 70710147801. 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 5-4-1 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
    5-4-170710-1478-15-4-270710-1478-01