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  5. NDC Package Code: 0310-3040-00 Saphnelo

NDC Package 0310-3040-00 Saphnelo

Anifrolumab 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:
0310-3040-00
Package Description:
1 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS
Product Code:
0310-3040
Proprietary Name:
Saphnelo
Non-Proprietary Name:
Anifrolumab
Substance Name:
Anifrolumab
Usage Information:
SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy [see Clinical Studies (14)].Limitations of UseThe efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.
11-Digit NDC Billing Format:
00310304000
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2565280 - anifrolumab-fnia 300 MG per 2 ML Injection
  • RxCUI: 2565280 - 2 ML anifrolumab-fnia 150 MG/ML Injection
  • RxCUI: 2565286 - Saphnelo 300 MG in 2 ML Injection
  • RxCUI: 2565286 - 2 ML anifrolumab-fnia 150 MG/ML Injection [Saphnelo]
  • RxCUI: 2565286 - 2 ML Saphnelo 150 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astrazeneca Pharmaceuticals Lp
    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):
  • ANIFROLUMAB 300 mg/2mL
    • Pharmacologic Class(es):
  • Type I Interferon Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Type I Interferon Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA761123
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-30-2021
    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 0310-3040-00 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00310304000J0491Inj anifrolumab-fnia 1mg1 mg21300300

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0310-3040-00?

    The NDC Packaged Code 0310-3040-00 is assigned to a package of 1 vial, glass in 1 carton / 2 ml in 1 vial, glass of Saphnelo, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0310-3040 included in the NDC Directory?

    Yes, Saphnelo with product code 0310-3040 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on July 30, 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 0310-3040-00?

    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 0310-3040-00?

    The 11-digit format is 00310304000. 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
    4-4-20310-3040-005-4-200310-3040-00