NDC Package 44087-1116-1 Gonal-f Rff Redi-ject

Follitropin Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
44087-1116-1
Package Description:
1 PACKAGE in 1 CARTON / .75 mL in 1 PACKAGE
Product Code:
Proprietary Name:
Gonal-f Rff Redi-ject
Non-Proprietary Name:
Follitropin
Substance Name:
Follitropin
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
11-Digit NDC Billing Format:
44087111601
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1594334 - GONAL-f RFF Pen 900 UNT in 1.5 ML Pen Injector
  • RxCUI: 1594334 - 1.5 ML follitropin alfa 600 UNT/ML Pen Injector [Gonal F]
  • RxCUI: 1594334 - 1.5 ML Gonal F 600 UNT/ML Pen Injector
  • RxCUI: 1594334 - Gonal F RFF Pen 900 UNT per 1.5 ML Pen Injector
  • RxCUI: 1594334 - Gonal F RFF Redi-ject 900 UNT per 1.5 ML Pen Injector
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Emd Serono, Inc.
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA021684
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-16-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 44087-1116-1?

    The NDC Packaged Code 44087-1116-1 is assigned to a 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.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 44087-1116 included in the NDC Directory?

    Yes, Gonal-f Rff Redi-ject with product code 44087-1116 is active and included in the NDC Directory. The product was first marketed by Emd Serono, Inc. on October 16, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 44087-1116-1?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 44087-1116-1?

    The 11-digit format is 44087111601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-144087-1116-15-4-244087-1116-01