Ganirelix Acetate Injection, Solution
NDC Package 68083-472-01

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

Package Information

Ganirelix Acetate injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-472 and is authorized under FDA application ANDA215658.

Identification & Billing

NDC Package Code
68083-472-01
Package Description
1 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
Product Code
68083-472
11-Digit Billing Format
68083047201
RxNorm Crosswalk
  • RxCUI: 855200 - ganirelix acetate 250 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 855200 - 0.5 ML ganirelix acetate 0.5 MG/ML Prefilled Syringe
  • RxCUI: 855200 - ganirelix acetate 0.5 MG/ML 0.5 ML Prefilled Syringe
  • RxCUI: 855200 - ganirelix acetate 250 MCG per 0.5 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Ganirelix Acetate
Non-Proprietary Name
Ganirelix Acetate
Substance Name
Ganirelix Acetate
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)
GANIRELIX ACETATE 250 ug/.5mL
Pharmacologic Class
Usage Information
Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA215658
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-28-2023
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 68083-472-01 identifies a specific commercial package of 1 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 ml in 1 syringe, glass of Ganirelix Acetate, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for subcutaneous use and contains ganirelix acetate 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 Gland Pharma Limited on February 28, 2023. The current certification is valid through December 31, 2026.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083047201. 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 (5-3-2)
68083-472-01
11-Digit CMS (5-4-2)
68083-0472-01

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