1. Home
  2. Labeler Index
  3. Gland Pharma Limited
  4. 68083-600
  5. NDC Package Code: 68083-600-01 Cetrorelix Acetate

NDC Package 68083-600-01 Cetrorelix Acetate

Kit - 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:
68083-600-01
Package Description:
1 TRAY in 1 CARTON / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01) * 1 mL in 1 SYRINGE (68083-599-01)
Product Code:
68083-600
Proprietary Name:
Cetrorelix Acetate
Non-Proprietary Name:
Cetrorelix Acetate
Usage Information:
Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
11-Digit NDC Billing Format:
68083060001
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Gland Pharma Limited
Dosage Form:
Kit - A packaged collection of related material.
Sample Package:
No
FDA Application Number:
ANDA218150
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-25-2024
Listing Expiration Date:
12-31-2025
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 68083-600-01?

The NDC Packaged Code 68083-600-01 is assigned to a package of 1 tray in 1 carton / 1 kit in 1 tray * 1 ml in 1 vial, single-dose (68083-598-01) * 1 ml in 1 syringe (68083-599-01) of Cetrorelix Acetate, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is kit and is administered via form.

Is NDC 68083-600 included in the NDC Directory?

Yes, Cetrorelix Acetate with product code 68083-600 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on April 25, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68083-600-01?

The 11-digit format is 68083060001. 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 5-3-2 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
5-3-268083-600-015-4-268083-0600-01