Padcev Injection, Powder, Lyophilized, For Solution
NDC Package 51144-030-01

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

Package Information

Padcev (enfortumab vedotin) injection is pADCEVTM is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.This indication is approved under accelerated approval based on tumor response rate [see Clinical Studies (14.1)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Seagen Inc., this product is identified by NDC 51144-030 and is authorized under FDA application BLA761137.

Identification & Billing

NDC Package Code
51144-030-01
Package Description
1 VIAL, SINGLE-DOSE in 1 BOX / 3 mL in 1 VIAL, SINGLE-DOSE
Product Code
51144-030
11-Digit Billing Format
51144003001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Padcev Ejfv
Non-Proprietary Name
Enfortumab Vedotin
Substance Name
Enfortumab Vedotin
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ENFORTUMAB VEDOTIN 30 mg/3mL
Usage Information
PADCEVTM is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.This indication is approved under accelerated approval based on tumor response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Regulatory & Marketing

Labeler Name
Seagen Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761137
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-18-2019
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9177
Source: ASP
Inj enfort vedo-ejfv 0.25mg
HCPCS Dosage 0.25 MG
Units / Pkg 120

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 51144-030-01 identifies a specific commercial package of 1 vial, single-dose in 1 box / 3 ml in 1 vial, single-dose of Padcev Ejfv, a human prescription drug labeled by Seagen Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains enfortumab vedotin 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 Seagen Inc. on December 18, 2019. The current certification is valid through December 31, 2026.

How is this Seagen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51144003001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
51144-030-01
11-Digit CMS (5-4-2)
51144-0030-01

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