Gonal-f Kit
NDC Package 44087-9030-1

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

Gonal-f (follitropin alfa) kits is gonal-f® (follitropin alfa for injection) is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH preparations or one of their excipients.High levels of FSH indicating primary gonadal failure.Uncontrolled thyroid or adrenal dysfunction.Sex hormone dependent tumors of the reproductive tract and accessory organs.An organic intracranial lesion such as a pituitary tumor. This formulation utilizes a kit delivery system. Marketed by Emd Serono, Inc., this product is identified by NDC 44087-9030 and is authorized under FDA application BLA020378.

Identification & Billing

NDC Package Code
44087-9030-1
Package Description
1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE
Product Code
44087-9030
11-Digit Billing Format
44087903001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gonal-f
Non-Proprietary Name
Follitropin Alfa
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Usage Information
Gonal-f® (follitropin alfa for injection) is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH preparations or one of their excipients.High levels of FSH indicating primary gonadal failure.Uncontrolled thyroid or adrenal dysfunction.Sex hormone dependent tumors of the reproductive tract and accessory organs.An organic intracranial lesion such as a pituitary tumor. And in women who exhibit:Abnormal uterine bleeding of undetermined origin (see "Selection of Patients").Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients").Pregnancy.

Regulatory & Marketing

Labeler Name
Emd Serono, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA020378
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-25-2004
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.

J3490
Source: PDAC
UNCLASSIFIED DRUGS
HCPCS Dosage 1 EA
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 44087-9030-1 identifies a specific commercial package of 1 kit in 1 carton * 1 ml in 1 vial * 1 ml in 1 syringe of Gonal-f, a human prescription drug labeled by Emd Serono, Inc.. This kit is formulated for subcutaneous use and contains 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 Emd Serono, Inc. on March 25, 2004. The current certification is valid through December 31, 2026.

How is this Emd Serono, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44087903001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
44087-9030-1
11-Digit CMS (5-4-2)
44087-9030-01

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