Increlex Injection
NDC Package 71863-216-04

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

Increlex (mecasermin) injection is severe Primary IGF-1 Deficiency (Primary IGFD)INCRELEX is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with:severe primary IGF-1 deficiency orgrowth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.Severe Primary IGF-1 deficiency (IGFD) is defined by:height standard deviation score ≤ –3.0 andbasal IGF-1 standard deviation score ≤ –3.0 andnormal or elevated growth hormone (GH). This formulation utilizes a injection delivery system. Marketed by Eton Pharmaceuticals, Inc., this product is identified by NDC 71863-216 and is authorized under FDA application BLA021839.

Identification & Billing

NDC Package Code
71863-216-04
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 4 mL in 1 VIAL, MULTI-DOSE
Product Code
71863-216
11-Digit Billing Format
71863021604
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Increlex
Non-Proprietary Name
Mecasermin
Substance Name
Mecasermin
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
MECASERMIN 40 mg/4mL
Usage Information
Severe Primary IGF-1 Deficiency (Primary IGFD)INCRELEX is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with:severe primary IGF-1 deficiency orgrowth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.Severe Primary IGF-1 deficiency (IGFD) is defined by:height standard deviation score ≤ –3.0 andbasal IGF-1 standard deviation score ≤ –3.0 andnormal or elevated growth hormone (GH).

Regulatory & Marketing

Labeler Name
Eton Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA021839
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-16-2025
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.

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.

J2170
Source: PDAC
INJECTION, MECASERMIN, 1 MG
HCPCS Dosage 1 MG
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 71863-216-04 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 4 ml in 1 vial, multi-dose of Increlex, a human prescription drug labeled by Eton Pharmaceuticals, Inc.. This injection is formulated for subcutaneous use and contains mecasermin 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 Eton Pharmaceuticals, Inc. on April 16, 2025. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71863021604. 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)
71863-216-04
11-Digit CMS (5-4-2)
71863-0216-04

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