1. Home
  2. Labeler Index
  3. Emd Serono, Inc.
  4. 44087-9070
  5. NDC Package Code: 44087-9070-1 Gonal-f

NDC Package 44087-9070-1 Gonal-f

Follitropin Alfa Kit Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
44087-9070-1
Package Description:
1 KIT in 1 CARTON * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE
Product Code:
44087-9070
Proprietary Name:
Gonal-f
Non-Proprietary Name:
Follitropin Alfa
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.
11-Digit NDC Billing Format:
44087907001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 351125 - follitropin alfa 600 UNT/ML Injectable Solution
  • RxCUI: 351993 - GONAL-f 600 UNT/ML Injectable Solution
  • RxCUI: 351993 - follitropin alfa 600 UNT/ML Injectable Solution [Gonal F]
  • RxCUI: 351993 - Gonal F 600 UNT/ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Emd Serono, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Sample Package:
    No
    FDA Application Number:
    BLA020378
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-25-2004
    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 44087-9070-1?

    The NDC Packaged Code 44087-9070-1 is assigned to a package of 1 kit in 1 carton * 2 ml in 1 vial * 2 ml in 1 syringe of Gonal-f, a human prescription drug labeled by Emd Serono, Inc.. The product's dosage form is kit and is administered via subcutaneous form.

    Is NDC 44087-9070 included in the NDC Directory?

    Yes, Gonal-f with product code 44087-9070 is active and included in the NDC Directory. The product was first marketed by Emd Serono, Inc. on March 25, 2004 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 44087-9070-1?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 44087-9070-1?

    The 11-digit format is 44087907001. 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
    5-4-144087-9070-15-4-244087-9070-01