Enfortumab Vedotin-ejfv For Injection
NDC Package 43624-014-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Enfortumab Vedotin-ejfv For Injection injection is a drug for further processing. This formulation utilizes a injection delivery system. Marketed by Bsp Pharmaceuticals S.p.a., this product is identified by NDC 43624-014.

Identification & Billing

NDC Package Code
43624-014-01
Package Description
120 VIAL, SINGLE-DOSE in 1 TRAY / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
43624-014
11-Digit Billing Format
43624001401

Clinical Specifications

Proprietary Name
Enfortumab Vedotin-ejfv For Injection
Non-Proprietary Name
Enfortumab Vedotin-ejfv For Injection
Substance Name
Enfortumab Vedotin-ejfv
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
ENFORTUMAB VEDOTIN-EJFV 20 mg/2mL

Regulatory & Marketing

Labeler Name
Bsp Pharmaceuticals S.p.a.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-05-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 43624-014-01 identifies a specific commercial package of 120 vial, single-dose in 1 tray / 2 ml in 1 vial, single-dose of Enfortumab Vedotin-ejfv For Injection (UNFINISHED drug), drug for further processing labeled by Bsp Pharmaceuticals S.p.a.. This injection is formulated for use and contains enfortumab vedotin-ejfv as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bsp Pharmaceuticals S.p.a. on January 05, 2024. The current certification is valid through December 31, 2026.

How is this Bsp Pharmaceuticals S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43624001401. 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)
43624-014-01
11-Digit CMS (5-4-2)
43624-0014-01

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