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  5. NDC Package Code: 80203-347-01 Enjaymo

NDC Package 80203-347-01 Enjaymo

Sutimlimab-jome Injection, Solution, Concentrate Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
80203-347-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 22 mL in 1 VIAL, SINGLE-DOSE
Product Code:
80203-347
Proprietary Name:
Enjaymo
Non-Proprietary Name:
Sutimlimab-jome
Substance Name:
Sutimlimab
Usage Information:
ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
11-Digit NDC Billing Format:
80203034701
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2591419 - sutimlimab-jome 1100 MG in 22 ML Injection
  • RxCUI: 2591419 - 22 ML sutimlimab-jome 50 MG/ML Injection
  • RxCUI: 2591419 - sutimlimab-jome 1100 MG per 22 ML Injection
  • RxCUI: 2591425 - Enjaymo 1100 MG in 22 ML Injection
  • RxCUI: 2591425 - 22 ML sutimlimab-jome 50 MG/ML Injection [Enjaymo]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bioverativ Therapeutics Inc.
    Dosage Form:
    Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SUTIMLIMAB 50 mg/mL
    • Pharmacologic Class(es):
  • Classical Complement Pathway Inhibitor - [EPC] (Established Pharmacologic Class)
  • Classical Complement Pathway Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA761164
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-04-2022
    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 80203-347-01?

    The NDC Packaged Code 80203-347-01 is assigned to a package of 1 vial, single-dose in 1 carton / 22 ml in 1 vial, single-dose of Enjaymo, a human prescription drug labeled by Bioverativ Therapeutics Inc.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

    Is NDC 80203-347 included in the NDC Directory?

    Yes, Enjaymo with product code 80203-347 is active and included in the NDC Directory. The product was first marketed by Bioverativ Therapeutics Inc. on February 04, 2022 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 80203-347-01?

    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 80203-347-01?

    The 11-digit format is 80203034701. 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
    5-3-280203-347-015-4-280203-0347-01