Enjaymo
NDC Package 80203-347-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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)]. Marketed by Bioverativ Therapeutics Inc., this product is identified by NDC 80203-347 and is authorized under FDA application BLA761164.

Identification & Billing

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
11-Digit Billing Format
80203034701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Enjaymo
Dosage Form
-
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)].

Regulatory & Marketing

Labeler Name
Bioverativ Therapeutics Inc.
FDA Application #
BLA761164
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-04-2022
Listing Expiration
12-31-2025
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80203-347-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 22 ml in 1 vial, single-dose of Enjaymo, labeled by Bioverativ Therapeutics Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bioverativ Therapeutics Inc. on February 04, 2022. The current certification is valid through December 31, 2025.

How is this Bioverativ Therapeutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80203034701. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
80203-347-01
11-Digit CMS (5-4-2)
80203-0347-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.