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  5. NDC Package Code: 0597-0035-10 Spevigo

NDC Package 0597-0035-10 Spevigo

Spesolimab-sbzo Injection 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:
0597-0035-10
Package Description:
2 VIAL, GLASS in 1 CARTON / 7.5 mL in 1 VIAL, GLASS
Product Code:
0597-0035
Proprietary Name:
Spevigo
Non-Proprietary Name:
Spesolimab-sbzo
Substance Name:
Spesolimab
Usage Information:
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults.
11-Digit NDC Billing Format:
00597003510
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2610422 - spesolimab-sbzo 450 MG in 7.5 ML Injection
  • RxCUI: 2610422 - 7.5 ML spesolimab-sbzo 60 MG/ML Injection
  • RxCUI: 2610422 - spesolimab-sbzo 450 MG per 7.5 ML Injection
  • RxCUI: 2610428 - Spevigo 450 MG in 7.5 ML Injection
  • RxCUI: 2610428 - 7.5 ML spesolimab-sbzo 60 MG/ML Injection [Spevigo]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, 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):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SPESOLIMAB 60 mg/mL
    • Pharmacologic Class(es):
  • Interleukin-36 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Interleukin-36 Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA761244
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    09-01-2022
    Listing Expiration Date:
    12-31-2025
    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 0597-0035-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00597003510J1747Inj, spesolimab-sbzo, 1 mg1 MG7.52450900

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0035-10?

    The NDC Packaged Code 0597-0035-10 is assigned to a package of 2 vial, glass in 1 carton / 7.5 ml in 1 vial, glass of Spevigo, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 0597-0035 included in the NDC Directory?

    Yes, Spevigo with product code 0597-0035 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on September 01, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0597-0035-10?

    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 0597-0035-10?

    The 11-digit format is 00597003510. 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 4-4-2 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
    4-4-20597-0035-105-4-200597-0035-10