Gonal-f Rff Redi-ject Injection, Solution
NDC Package 44087-1116-1

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

Package Information

Gonal-f Rff Redi-ject (follitropin) injection is gonal-f® RFF Redi-ject® is contraindicated in women who exhibit:Prior hypersensitivity to recombinant FSH productsHigh levels of FSH indicating primary gonadal failurePregnancy Gonal-f® RFF Redi-ject® may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. This formulation utilizes a injection, solution delivery system. Marketed by Emd Serono, Inc., this product is identified by NDC 44087-1116 and is authorized under FDA application BLA021684.

Identification & Billing

NDC Package Code
44087-1116-1
Package Description
1 PACKAGE in 1 CARTON / .75 mL in 1 PACKAGE
Product Code
44087-1116
11-Digit Billing Format
44087111601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gonal-f Rff Redi-ject
Non-Proprietary Name
Follitropin
Substance Name
Follitropin
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
FOLLITROPIN 450 [iU]/.75mL
Pharmacologic Class
Usage Information
Gonal-f® RFF Redi-ject® is contraindicated in women who exhibit:Prior hypersensitivity to recombinant FSH productsHigh levels of FSH indicating primary gonadal failurePregnancy Gonal-f® RFF Redi-ject® may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Gonal-f® RFF Redi-ject® is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1.1, 1.2)]Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusAbnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome

Regulatory & Marketing

Labeler Name
Emd Serono, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA021684
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-16-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 44087-1116-1 identifies a specific commercial package of 1 package in 1 carton / .75 ml in 1 package of Gonal-f Rff Redi-ject, a human prescription drug labeled by Emd Serono, Inc.. This injection, solution is formulated for subcutaneous use and contains follitropin 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 October 16, 2013. 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: 44087111601. 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 (5-4-1)
44087-1116-1
11-Digit CMS (5-4-2)
44087-1116-01

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