Imlygic Injection, Suspension
NDC Package 55513-079-01

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

Imlygic (talimogene laherparepvec) injection is a medication used to treat a certain type of skin cancer (melanoma). This formulation utilizes a injection, suspension delivery system. Marketed by Amgen Inc, this product is identified by NDC 55513-079 and is authorized under FDA application BLA125518.

Identification & Billing

NDC Package Code
55513-079-01
Package Description
1 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code
55513-079
11-Digit Billing Format
55513007901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1721278 - talimogene laherparepvec 1,000,000 PFU in 1 mL Injection
  • RxCUI: 1721278 - 1 ML talimogene laherparepvec 1000000 UNT/ML Injection
  • RxCUI: 1721278 - talimogene laherparepvec 1,000,000 PFU per 1 ML Injection
  • RxCUI: 1721283 - IMLYGIC 1,000,000 PFU in 1 mL Injection
  • RxCUI: 1721283 - 1 ML talimogene laherparepvec 1000000 UNT/ML Injection [Imlygic]

Clinical Specifications

Proprietary Name
Imlygic
Non-Proprietary Name
Talimogene Laherparepvec
Substance Name
Talimogene Laherparepvec
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intralesional - Administration within or introduced directly into a localized lesion.
Active Ingredient(s)
TALIMOGENE LAHERPAREPVEC 100000000 [PFU]/mL
Usage Information
This medication is used to treat a certain type of skin cancer (melanoma). It contains a live virus (cold sore virus) that has been weakened. Talimogene laherparepvec infects the cancer cells and works by slowing or stopping their growth.

Regulatory & Marketing

Labeler Name
Amgen Inc
Product Type
Human Prescription Drug
FDA Application #
BLA125518
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-02-2015
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.

J9325
Source: ASP
Inj talimogene laherparepvec
HCPCS Dosage 1 million�PFU
Units / Pkg 100

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 55513-079-01 identifies a specific commercial package of 1 vial in 1 carton / 1 ml in 1 vial of Imlygic, a human prescription drug labeled by Amgen Inc. This injection, suspension is formulated for intralesional use and contains talimogene laherparepvec 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 Amgen Inc on November 02, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain type of skin cancer (melanoma). It contains a live virus (cold sore virus) that has been weakened. Talimogene laherparepvec infects the cancer cells and works by slowing or stopping their growth.

How is this Amgen Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513007901. 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)
55513-079-01
11-Digit CMS (5-4-2)
55513-0079-01

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