Quick answers
- What is Ganirelix acetate used for?
- The FDA-approved label (Ganirelix Acetate, Mullan Pharmaceutical Inc., May 11, 2026) says: “Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ganirelix acetate have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ganirelix acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ganirelix acetate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ganirelix acetate?
- 10 companies list prescription products of Ganirelix acetate in the FDA NDC Directory, including Mullan Pharmaceutical Inc., Xiromed, LLC and Lupin Pharmaceuticals, Inc..
What Ganirelix acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
— FDA label: Ganirelix Acetate, Mullan Pharmaceutical Inc., effective May 11, 2026. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Fyremadel |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ganirelix acetate 250 ug/0.5 mL injection | Generic | $56.04 per mL |
| ganirelix acetate 250 ug/0.5 mL injection, solution | Generic | $56.04 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mullan Pharmaceutical Inc.1 product
- Xiromed, LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- Fresenius Kabi USA, LLC1 product
- Ferring Pharmaceuticals Inc.1 product
- Gland Pharma Limited1 product
- Qilu Pharmaceutical Co., Ltd.1 product
- Amphastar Pharmaceuticals, Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
- Organon LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021057 GANIRELIX ACETATE | Organon USA Organon | July 29, 1999 | 14, latest September 23, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
Generic approvals (6)
- ANDA204246Sun Pharm · November 30, 2018
- ANDA212613Amphastar Pharms Inc · April 7, 2022
- ANDA214996Meitheal · June 6, 2022
- ANDA215658Gland · February 28, 2023
- ANDA216075Lupin · November 16, 2023
- ANDA218855Qilu · April 23, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 13, 2025 · Class II · Ongoing · D-0220-2026
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin — Lupin Pharmaceuticals Inc.
-
April 19, 2023 · Class II · Terminated · D-0569-2023
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC — Sun Pharmaceutical Industries Ltd.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 855200 |
|---|---|
| SPL set ID of the quoted label | 420ce739-2756-4fb4-8a4e-5fab501ab973 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA021057, 6 ANDA |
| Active ingredients (FDA) | GANIRELIX ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ganirelix Acetate, Mullan Pharmaceutical Inc., effective May 11, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →