Lymphir Injection, Powder, Lyophilized, For Solution
NDC Package 52658-7777-1

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

Lymphir (denileukin diftitox-cxdl) injection is lYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Citius Pharmaceuticals, Inc., this product is identified by NDC 52658-7777 and is authorized under FDA application BLA761312.

Identification & Billing

NDC Package Code
52658-7777-1
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
52658-7777
11-Digit Billing Format
52658777701
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
Lymphir
Non-Proprietary Name
Denileukin Diftitox-cxdl
Substance Name
Denileukin Diftitox
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)
DENILEUKIN DIFTITOX 300 ug/2mL
Pharmacologic Class
Usage Information
LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Regulatory & Marketing

Labeler Name
Citius Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761312
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-01-2025
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.

J9161
Source: PDAC
INJECTION, DENILEUKIN DIFTITOX-CXDL, 1 MCG
HCPCS Dosage 1 MCG
Units / Pkg

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 52658-7777-1 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose of Lymphir, a human prescription drug labeled by Citius Pharmaceuticals, 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 denileukin diftitox 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 Citius Pharmaceuticals, Inc. on March 01, 2025. The current certification is valid through December 31, 2026.

How is this Citius Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52658777701. 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 (5-4-1)
52658-7777-1
11-Digit CMS (5-4-2)
52658-7777-01

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