NDC Package 70257-561-02 Lioresal (baclofen)

Baclofen Injection Intrathecal - 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:
70257-561-02
Package Description:
2 AMPULE in 1 BOX / 5 mL in 1 AMPULE (70257-561-05)
Product Code:
Proprietary Name:
Lioresal (baclofen)
Non-Proprietary Name:
Baclofen
Substance Name:
Baclofen
Usage Information:
Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). It works by helping to relax the muscles.
11-Digit NDC Billing Format:
70257056102
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1666613 - baclofen 40 MG in 20 ML (2,000 MCG/ML) Injection
  • RxCUI: 1666613 - 20 ML baclofen 2 MG/ML Injection
  • RxCUI: 1666613 - baclofen 40,000 MCG per 20 ML Injection
  • RxCUI: 1666620 - LIORESAL INTRATHECAL 40 MG in 20 ML (2,000 MCG/ML) Injection
  • RxCUI: 1666620 - 20 ML baclofen 2 MG/ML Injection [Lioresal]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Saol Therapeutics Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA020075
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-12-2022
    End Marketing Date:
    11-30-2024
    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 70257-561-02 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    70257056102J0475Baclofen 10 mg injection10 MG5212

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    Frequently Asked Questions

    What is NDC 70257-561-02?

    The NDC Packaged Code 70257-561-02 is assigned to a package of 2 ampule in 1 box / 5 ml in 1 ampule (70257-561-05) of Lioresal (baclofen), a human prescription drug labeled by Saol Therapeutics Inc.. The product's dosage form is injection and is administered via intrathecal form.

    Is NDC 70257-561 included in the NDC Directory?

    Yes, Lioresal (baclofen) with product code 70257-561 is active and included in the NDC Directory. The product was first marketed by Saol Therapeutics Inc. on June 12, 2022.

    What is the NDC billing unit for package 70257-561-02?

    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 70257-561-02?

    The 11-digit format is 70257056102. 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
    5-3-270257-561-025-4-270257-0561-02