Neulasta Solution
NDC Package 55513-099-01

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

Package Information

Neulasta (pegfilgrastim) solution is pegfilgrastim is a man-made version of a certain natural substance made in your body. This formulation utilizes a solution delivery system. Marketed by Amgen, Inc, this product is identified by NDC 55513-099 and is authorized under FDA application BLA125031.

Identification & Billing

NDC Package Code
55513-099-01
Package Description
1 VIAL in 1 CARTON / .4 mL in 1 VIAL
Product Code
55513-099
11-Digit Billing Format
55513009901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Neulasta
Non-Proprietary Name
Pegfilgrastim
Substance Name
Pegfilgrastim
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
PEGFILGRASTIM 4 mg/.4mL
Pharmacologic Class
Usage Information
Pegfilgrastim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Pegfilgrastim is given to people whose ability to make white blood cells is reduced due to chemotherapy. Some brands may also be used to increase white blood cells after exposure to large amounts of radiation. This monograph is about the following pegfilgrastim products: pegfilgrastim, pegfilgrastim-cbqv, pegfilgrastim-jmdb, and pegfilgrastim-bmez.

Regulatory & Marketing

Labeler Name
Amgen, Inc
Product Type
Human Prescription Drug
FDA Application #
BLA125031
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-31-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55513-099-01 identifies a specific commercial package of 1 vial in 1 carton / .4 ml in 1 vial of Neulasta, a human prescription drug labeled by Amgen, Inc. This solution is formulated for subcutaneous use and contains pegfilgrastim 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 March 31, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Pegfilgrastim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Pegfilgrastim is given to people whose ability to make white blood cells is reduced due to chemotherapy. Some brands may also be used to increase white blood cells after exposure to large amounts of radiation. This monograph is about the following pegfilgrastim products: pegfilgrastim, pegfilgrastim-cbqv, pegfilgrastim-jmdb, and pegfilgrastim-bmez.

How is this Amgen, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513009901. 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)
55513-099-01
11-Digit CMS (5-4-2)
55513-0099-01

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