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Ganirelix Acetate 250 ug/.5mL Injection, Solution, 1 syringe — NDC 78206-0138-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ganirelix Acetate 250 ug/.5mL Injection, Solution, 1 syringe — NDC 78206-138-01 (Billing 78206-0138-01)

by Organon LLC · 1 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

This is a package of 1 syringe of Ganirelix Acetate 250 ug/.5mL Injection, Solution from Organon LLC, marketed since Jun 2021 and currently FDA-listed.

NDC 78206-0138-01
🏷️ FDA NDC (as labeled) 78206-138-01 billing pads the product segment with a zero
This package
Contains1 syringe Pack sizes2 compare ↓
Product page 78206-0138-02 Also comes in: 1 mL 78206-138-02
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Ganirelix Acetate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 13, 2025 — Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. (Lupin Pharmaceuticals Inc.) · FDA recall D-0220-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 78206-138-01
Product NDC 78206-138
11-digit billing NDC 78206013801
NCPDP billing unit ML — per mL (volume)
RxCUI 855200
UNII 56U7906FQW
Application # NDA021057
SPL Set ID 32fb74ff-993a-49fe-8943-e029372b863e
Established class (EPC) Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of action Gonadotropin Releasing Hormone Receptor Antagonists
Physiologic effect Decreased GnRH Secretion
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-01
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance GANIRELIX ACETATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 3009004010E520
GPI class Ganirelix Acetate
GCN Seq No 047336
GCN 12283
HICL code 025154
Ingredient (HICL) Ganirelix Acetate
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P1
Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones
HIC3 code P1N
Therapeutic class — specific (HIC3) Lhrh(Gnrh) Antagonist,Pituitary Suppressant Agents
AHFS code 68:18.04.00
AHFS class Antigonadtropins
FDB label name GANIRELIX ACET 250 MCG/0.5 ML
FDB brand name Ganirelix Acetate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 047336
  • GCN: 12283
  • GPI-14 (Medi-Span): 3009004010E520
  • HICL (First Databank): 025154
  • AHFS class code: 68:18.04.00
  • RxCUI (RxNorm): 855200
Why two NDCs? The FDA registers this code as 78206-138-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 78206-0138-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Gonadotropin Releasing Hormone Receptor Antagonist class.

Pharmacologic class Gonadotropin Releasing Hormone Receptor Antagonist
Drug family (ATC) Anti-gonadotropin-releasing hormones
How it works Gonadotropin Releasing Hormone Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GANIRELIX ACET 250 MCG/0.5 ML Ingredient Ganirelix Acetate

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3490 No ASP payment limit on file for J3490 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)78206-138-01
11-digit billing NDC78206-0138-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3490
DescriptorUNCLASSIFIED DRUGS
Billing units / pkg1 units
How the units are derivedThis package is 0.5 ML; the HCPCS unit is 1 EA, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
78206-0138-01 You're viewing this 1 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS — — 2021-06-01 — Active
78206-0138-02 78206-138-02 Main listing 1 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS $62.35 / mL $62.35 2024-02-16 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 syringe — 1 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 ml in 1 syringe, glass.
How does this package differ from NDC 78206-0138-02?
Both are Ganirelix Acetate 250 ug/.5mL Injection, Solution — the drug itself is identical. This page's package is the 1 syringe one, while NDC 78206-0138-02 is the 1 syringe package.
What NDC number is used to bill for this package of Ganirelix Acetate 250 ug/.5mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ganirelix Acetate 250 ug/.5mL 00548-5001-00 Amphastar 1 syringe $62.347 AP Availability likely —
Fyremadel 250 ug/.5mL 55566-1010-01 Ferring 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 65219-0028-05 Fresenius 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 70700-0327-98 Xiromed 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 70748-0274-01 Lupin 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 71288-0554-80 Meitheal 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 83301-0082-01 Mullan 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 67184-0574-01 Qilu 1 syringe — AP FDA listed —
Ganirelix Acetate 250 ug/.5mL 68083-0472-01 Gland 1 syringe — AP FDA listed —
Ganirelix Acetate 250 ug/.5mLthis 78206-0138-01 Organon 1 syringe — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.1 mg / 0.5 mL UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 23.5 mg / 0.5 mL UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerOrganon LLC
Application holderORGANON USA LLC A SUB OF ORGANON AND CO
FDA applicationNDA021057 (NDA)
Labeler code78206
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio70 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

INDICATIONS AND USAGE Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION After initiating FSH therapy on Day 2 or 3 of the cycle, Ganirelix Acetate Injection 250 mcg may be administered subcutaneously once daily during the mid to late portion of the follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced. Treatment with Ganirelix Acetate should be continued daily until the day of hCG administration.

When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS (Ovarian Hyperstimulation Syndrome). Directions for Using Ganirelix Acetate Injection Ganirelix Acetate Injection is supplied in a single dose, sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only.

Air bubble(s) may be seen in the pre-filled syringe. This is expected, and removal of the air bubble(s) is not needed. Wash hands thoroughly with soap and water.

The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and let the disinfectant dry for at least one minute before proceeding.

With syringe held upward, remove needle cover. Pinch up a large area of skin between the finger and thumb. Vary the injection site a little with each injection.

The needle should be inserted at the base of the pinched-up skin at an angle of 45–90° to the skin surface. When the needle is correctly positioned, it will be difficult to draw back on the plunger. If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery.

If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin. Alternatively, remove the needle and use a new, sterile, prefilled syringe. Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within one or two minutes.

Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged. Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant. Use the sterile, prefilled syringe only once.

Discard the unused portion and dispose of it properly.

⛔ Contraindications 54 words ▾

CONTRAINDICATIONS Ganirelix Acetate Injection is contraindicated under the following conditions: Known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex which may be contained in the rigid needle shield (see HOW SUPPLIED ). Known hypersensitivity to GnRH or any other GnRH analog. Known or suspected pregnancy (see PRECAUTIONS ).

⚠️ Warnings 41 words ▾

WARNINGS Ganirelix Acetate Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Ganirelix Acetate, pregnancy must be excluded. Safe use of Ganirelix Acetate during pregnancy has not been established (see CONTRAINDICATIONS and PRECAUTIONS ).

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS The safety of Ganirelix Acetate Injection was evaluated in two randomized, parallel-group, multicenter controlled clinical studies. Treatment duration for Ganirelix Acetate ranged from 1 to 14 days. Table IV represents adverse events (AEs) from first day of Ganirelix Acetate administration until confirmation of pregnancy by ultrasound at an incidence of ≥ 1% in Ganirelix Acetate-treated subjects without regard to causality.

TABLE IV: Incidence of common adverse events (Incidence ≥ 1% in Ganirelix Acetate-treated subjects). Completed controlled clinical studies (All-subjects-treated group). Adverse Events Occurring in ≥ 1% Ganirelix Acetate N=794 % (n) Abdominal Pain (gynecological) 4.8 (38) Death Fetal 3.7 (29) Headache 3.0 (24) Ovarian Hyperstimulation Syndrome 2.4 (19) Vaginal Bleeding 1.8 (14) Injection Site Reaction 1.1 (9) Nausea 1.1 (9) Abdominal Pain (gastrointestinal) 1.0 (8) During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylaxis (including anaphylactic shock), angioedema and urticaria have been reported with Ganirelix Acetate, as early as with the first dose (see PRECAUTIONS ).

Congenital Anomalies An observational study in more than 1000 newborns compared the incidence of congenital anomalies in newborns of women administered Ganirelix Acetate to historical controls of a GnRH agonist. This study demonstrated that the incidence of congenital anomalies in children born after COH treatment in women using Ganirelix Acetate was comparable with that reported after a COH treatment cycle using a GnRH agonist. The incidence of congenital malformations after some Assisted Reproductive Technologies (ART) [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception.

This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. The causal relationship between these congenital anomalies and Ganirelix Acetate Injection is unknown.

🔄 Drug Interactions 10 words ▾

Drug Interactions No formal drug-drug interaction studies have been performed.

🤰 Pregnancy 127 words ▾

Pregnancy Ganirelix Acetate Injection is contraindicated in pregnant women. When administered from Day 7 to near term to pregnant rats and rabbits at doses up to 10 and 30 mcg/day (approximately 0.4 to 3.2 times the human dose based on body surface area), Ganirelix Acetate increased the incidence of litter resorption. There was no increase in fetal abnormalities.

No treatment-related changes in fertility, physical, or behavioral characteristics were observed in the offspring of female rats treated with Ganirelix Acetate during pregnancy and lactation. The effects on fetal resorption are logical consequences of the alteration in hormonal levels brought about by the antigonadotropic properties of this drug and could result in fetal loss in humans. Therefore, this drug should not be used in pregnant women (see CONTRAINDICATIONS ).

🧓 Geriatric Use 20 words ▾

Geriatric Use Clinical studies with Ganirelix Acetate Injection did not include a sufficient number of subjects aged 65 and over.

🆘 Overdosage 14 words ▾

OVERDOSAGE There have been no reports of overdosage with Ganirelix Acetate Injection in humans.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY The pulsatile release of GnRH stimulates the synthesis and secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The frequency of LH pulses in the mid and late follicular phase is approximately 1 pulse per hour. These pulses can be detected as transient rises in serum LH.

At midcycle, a large increase in GnRH release results in an LH surge. The midcycle LH surge initiates several physiologic actions including: ovulation, resumption of meiosis in the oocyte, and luteinization. Luteinization results in a rise in serum progesterone with an accompanying decrease in estradiol levels.

Ganirelix Acetate acts by competitively blocking the GnRH receptors on the pituitary gonadotroph and subsequent transduction pathway. It induces a rapid, reversible suppression of gonadotropin secretion. The suppression of pituitary LH secretion by Ganirelix Acetate is more pronounced than that of FSH.

An initial release of endogenous gonadotropins has not been detected with Ganirelix Acetate, which is consistent with an antagonist effect. Upon discontinuation of Ganirelix Acetate, pituitary LH and FSH levels are fully recovered within 48 hours. Pharmacokinetics The pharmacokinetic parameters of single and multiple injections of Ganirelix Acetate Injection in healthy adult females are summarized in Table I .

Steady-state serum concentrations are reached after 3 days of treatment. The pharmacokinetics of Ganirelix Acetate are dose-proportional in the dose range of 125 to 500 mcg. TABLE I: Mean (SD) pharmacokinetic parameters of 250 mcg of Ganirelix Acetate following a single subcutaneous (SC) injection (n=15) and daily SC injections (n=15) for seven days. t max h t ½ h C max ng/mL AUC ng∙h/mL CL/F L/h V d /F L t max Time to maximum concentration t ½ Elimination half-life C max Maximum serum concentration AUC Area under the curve; Single dose: AUC 0–∞ ; multiple dose: AUC 0–24 V d Volume of distribution CL Clearance = Dose/AUC 0–∞ F Absolute bioavailability Ganirelix Acetate single dose 1.1 (0.3) 12.8 (4.3) 14.8 (3.2) 96 (12) 2.4 (0.2) Based on intravenous administration 43.7 (11.4) Ganirelix Acetate multiple dose 1.1 (0.2) 16.2 (1.6) 11.2 (2.4) 77.1 (9.8) 3.3 (0.4) 76.5 (10.3) Absorption Ganirelix Acetate is rapidly absorbed following subcutaneous injection with maximum serum concentrations reached approximately one hour after dosing.

The mean absolute bioavailability of Ganirelix Acetate following a single 250 mcg subcutaneous injection to healthy female volunteers is 91.1%. Distribution The mean (SD) volume of distribution of Ganirelix Acetate in healthy females following intravenous administration of a single 250-mcg dose is 43.7 (11.4) liters (L). In vitro protein binding to human plasma is 81.9%.

Metabolism Following single-dose intravenous administration of radiolabeled Ganirelix Acetate to healthy female volunteers, Ganirelix Acetate is the major compound present in the plasma (50–70% of total radioactivity in the plasma) up to 4 hours and urine (17.1–18.4% of administered dose) up to 24 hours. Ganirelix Acetate is not found in the feces. The 1–4 peptide and 1–6 peptide of Ganirelix Acetate are the primary metabolites observed in the feces.

Excretion On average, 97.2% of the total radiolabeled Ganirelix Acetate dose is recovered in the feces and urine (75.1% and 22.1%, respectively) over 288 h following intravenous single dose administration of 1 mg [ 14 C]-Ganirelix Acetate. Urinary excretion is virtually complete in 24 h, whereas fecal excretion starts to plateau 192 h after dosing. Special Populations The pharmacokinetics of Ganirelix Acetate Injection have not been determined in special populations such as geriatric, pediatric, renally impaired and hepatically impaired patients (see PRECAUTIONS ).

Drug-Drug Interactions Formal in vivo or in vitro drug-drug interaction studies have not been conducted (see PRECAUTIONS ). Since Ganirelix Acetate can suppress the secretion of pituitary gonadotropins,… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 168 words ▾

HOW SUPPLIED Ganirelix Acetate Injection is supplied in a carton containing one of the following: Disposable, ready for use, single dose, sterile, prefilled 1 mL glass syringes containing 250 mcg/0.5 mL aqueous solution of Ganirelix Acetate closed with a rubber piston that does not contain latex. Each Ganirelix Acetate sterile, prefilled syringe is affixed with a 27 gauge × ½-inch needle closed by a needle shield of dry natural rubber/latex which comes into contact with this product . (See CONTRAINDICATIONS and PRECAUTIONS, General .), NDC No.

78206-138-01 Disposable, ready to use, single dose, sterile, prefilled 1 mL glass syringe containing 250 mcg/0.5 mL aqueous solution of Ganirelix Acetate closed with a plunger stopper. Each Ganirelix Acetate sterile, prefilled syringe is affixed with a 27 gauge x ½ inch staked needle closed by a rigid needle shield (RNS) not made with natural rubber latex, NDC No. 78206-138-02.

Storage Store at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Protect from light.

📦 Storage and Handling 22 words ▾

Storage Store at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Protect from light.

📋 Description 139 words ▾

DESCRIPTION Ganirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N 9 ,N 10 -diethyl-D-homoarginyl-L-leucyl-N 9 ,N 10 -diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate.

The molecular weight for Ganirelix Acetate is 1570.4 as an anhydrous free base. The structural formula is as follows: Ganirelix Acetate Ganirelix Acetate Injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF.

Image of Ganirelix Acetate Chemical Structure

💬 Information for Patients 50 words ▾

Information for Patients Prior to therapy with Ganirelix Acetate Injection, patients should be informed of the duration of treatment and monitoring procedures that will be required. The risk of possible adverse reactions should be discussed (see ADVERSE REACTIONS ). Ganirelix Acetate should not be prescribed if the patient is pregnant.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalized and local), including anaphylaxis (including anaphylactic shock), angioedema and urticaria, have been reported with Ganirelix Acetate, as early as with the first dose, during post-marketing surveillance (see ADVERSE REACTIONS ). If a hypersensitivity reaction is suspected, Ganirelix Acetate should be discontinued and appropriate treatment administered.

In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions. The rigid needle shield of this product may contain dry natural rubber/latex which comes into contact with this product and may cause allergic reactions (see CONTRAINDICATIONS and HOW SUPPLIED ). Information for Patients Prior to therapy with Ganirelix Acetate Injection, patients should be informed of the duration of treatment and monitoring procedures that will be required.

The risk of possible adverse reactions should be discussed (see ADVERSE REACTIONS ). Ganirelix Acetate should not be prescribed if the patient is pregnant. Laboratory Tests A neutrophil count ≥ 8.3 (x 10 9 /L) was noted in 11.9% (up to 16.8 x 10 9 /L) of all subjects treated within the adequate and well-controlled clinical trials.

In addition, downward shifts within the Ganirelix Acetate Injection group were observed for hematocrit and total bilirubin. The clinical significance of these findings was not determined. Drug Interactions No formal drug-drug interaction studies have been performed.

Carcinogenesis and Mutagenesis, Impairment of Fertility Long-term toxicity studies in animals have not been performed with Ganirelix Acetate Injection to evaluate the carcinogenic potential of the drug. Ganirelix Acetate did not induce a mutagenic response in the Ames test (S. typhimurium and E. coli ) or produce chromosomal aberrations in in vitro assay using Chinese Hamster Ovary cells. Pregnancy Ganirelix Acetate Injection is contraindicated in pregnant women.

When administered from Day 7 to near term to pregnant rats and rabbits at doses up to 10 and 30 mcg/day (approximately 0.4 to 3.2 times the human dose based on body surface area), Ganirelix Acetate increased the incidence of litter resorption. There was no increase in fetal abnormalities. No treatment-related changes in fertility, physical, or behavioral characteristics were observed in the offspring of female rats treated with Ganirelix Acetate during pregnancy and lactation.

The effects on fetal resorption are logical consequences of the alteration in hormonal levels brought about by the antigonadotropic properties of this drug and could result in fetal loss in humans. Therefore, this drug should not be used in pregnant women (see CONTRAINDICATIONS ). Nursing Mothers Ganirelix Acetate Injection should not be used by lactating women.

It is not known whether this drug is excreted in human milk. Geriatric Use Clinical studies with Ganirelix Acetate Injection did not include a sufficient number of subjects aged 65 and over.

🍼 Nursing Mothers 24 words ▾

Nursing Mothers Ganirelix Acetate Injection should not be used by lactating women. It is not known whether this drug is excreted in human milk.

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics The pharmacokinetic parameters of single and multiple injections of Ganirelix Acetate Injection in healthy adult females are summarized in Table I . Steady-state serum concentrations are reached after 3 days of treatment. The pharmacokinetics of Ganirelix Acetate are dose-proportional in the dose range of 125 to 500 mcg.

TABLE I: Mean (SD) pharmacokinetic parameters of 250 mcg of Ganirelix Acetate following a single subcutaneous (SC) injection (n=15) and daily SC injections (n=15) for seven days. t max h t ½ h C max ng/mL AUC ng∙h/mL CL/F L/h V d /F L t max Time to maximum concentration t ½ Elimination half-life C max Maximum serum concentration AUC Area under the curve; Single dose: AUC 0–∞ ; multiple dose: AUC 0–24 V d Volume of distribution CL Clearance = Dose/AUC 0–∞ F Absolute bioavailability Ganirelix Acetate single dose 1.1 (0.3) 12.8 (4.3) 14.8 (3.2) 96 (12) 2.4 (0.2) Based on intravenous administration 43.7 (11.4) Ganirelix Acetate multiple dose 1.1 (0.2) 16.2 (1.6) 11.2 (2.4) 77.1 (9.8) 3.3 (0.4) 76.5 (10.3) Absorption Ganirelix Acetate is rapidly absorbed following subcutaneous injection with maximum serum concentrations reached approximately one hour after dosing.

The mean absolute bioavailability of Ganirelix Acetate following a single 250 mcg subcutaneous injection to healthy female volunteers is 91.1%. Distribution The mean (SD) volume of distribution of Ganirelix Acetate in healthy females following intravenous administration of a single 250-mcg dose is 43.7 (11.4) liters (L). In vitro protein binding to human plasma is 81.9%.

Metabolism Following single-dose intravenous administration of radiolabeled Ganirelix Acetate to healthy female volunteers, Ganirelix Acetate is the major compound present in the plasma (50–70% of total radioactivity in the plasma) up to 4 hours and urine (17.1–18.4% of administered dose) up to 24 hours. Ganirelix Acetate is not found in the feces. The 1–4 peptide and 1–6 peptide of Ganirelix Acetate are the primary metabolites observed in the feces.

Excretion On average, 97.2% of the total radiolabeled Ganirelix Acetate dose is recovered in the feces and urine (75.1% and 22.1%, respectively) over 288 h following intravenous single dose administration of 1 mg [ 14 C]-Ganirelix Acetate. Urinary excretion is virtually complete in 24 h, whereas fecal excretion starts to plateau 192 h after dosing.

🔬 Clinical Studies ~3 min read ▾

Clinical Studies The efficacy of Ganirelix Acetate Injection was established in two adequate and well-controlled clinical studies which included women with normal endocrine and pelvic ultrasound parameters. The studies intended to exclude subjects with polycystic ovary syndrome (PCOS) and subjects with low or no ovarian reserve. One cycle of study medication was administered to each randomized subject.

For both studies, the administration of exogenous recombinant FSH [Follistim ® (follitropin beta for injection)] 150 IU daily was initiated on the morning of Day 2 or 3 of a natural menstrual cycle. Ganirelix Acetate Injection was administered on the morning of Day 7 or 8 (Day 6 of recombinant FSH administration). The dose of recombinant FSH administered was adjusted according to individual responses starting on the day of initiation of Ganirelix Acetate.

Both recombinant FSH and Ganirelix Acetate were continued daily until at least three follicles were 17 mm or greater in diameter at which time hCG [Pregnyl ® (chorionic gonadotropin for injection, USP)] was administered. Following hCG administration, Ganirelix Acetate and recombinant FSH administration were discontinued. Oocyte retrieval, followed by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), was subsequently performed.

In a multicenter, double-blind, randomized, dose-finding study, the safety and efficacy of Ganirelix Acetate Injection were evaluated for the prevention of LH surges in women undergoing COH with recombinant FSH. Ganirelix Acetate Injection doses ranging from 62.5 mcg to 2000 mcg and recombinant FSH were administered to 332 patients undergoing COH for IVF (see TABLE II ). Median serum LH on the day of hCG administration decreased with increasing doses of Ganirelix Acetate.

Median serum E 2 (17 β -estradiol) on the day of hCG administration was 1475, 1110, and 1160 pg/mL for the 62.5-, 125-, and 250-mcg doses, respectively. Lower peak serum E 2 levels of 823, 703, and 441 pg/mL were seen at higher doses of Ganirelix Acetate 500, 1000, and 2000 mcg, respectively. The highest pregnancy and implantation rates were achieved with the 250-mcg dose of Ganirelix Acetate Injection as summarized in Table II .

TABLE II: Results from the multicenter, double-blind, randomized, dose-finding study to assess the efficacy of Ganirelix Acetate Injection to prevent premature LH surges in women undergoing COH with recombinant FSH. Daily dose (mcg) of Ganirelix Acetate Injection 62.5 mcg 125 mcg 250 mcg 500 mcg 1000 mcg 2000 mcg (Protocol 38602) No. subjects receiving Ganirelix Acetate 31 66 70 69 66 30 No. subjects with ET ET: Embryo Transfer 27 61 62 54 61 27 No. of subjects with LH rise ≥ 10 mIU/mL Following initiation of Ganirelix Acetate therapy.

Includes subjects who have complied with daily injections 4 6 1 0 0 0 Serum LH (mIU/mL) on day of hCG Median values 3.6 2.5 1.7 1.0 0.6 0.3 5 th –95 th percentiles 0.6–19.9 0.6–11.4 < 0.25–6.4 0.4–4.7 < 0.25–2.2 < 0.25–0.8 Serum E 2 (pg/mL) on day of hCG 1475 1110 1160 823 703 441 5 th –95 th percentiles 645–3720 424–3780 384–3910 279–2720 284–2360 166–1940 Vital pregnancy rate As evidenced by ultrasound at 5–6 weeks following ET per attempt, n (%) 7 (22.6) 17 (25.8) 25 (35.7) 8 (11.6) 9 (13.6) 2 (6.7) per transfer, n (%) 7 (25.9) 17 (27.9) 25 (40.3) 8 (14.8) 9 (14.8) 2 (7.4) Implantation rate (%) Mean (standard deviation) 14.2 (26.8) 16.3 (30.5) 21.9 (30.6) 9.0 (23.7) 8.5 (21.7) 4.9 (20.1) Transient LH rises alone were not deleterious to achieving pregnancy with Ganirelix Acetate at doses of 125 mcg (3/6 subjects) and 250 mcg (1/1 subjects).

In addition, none of the subjects with LH rises ≥ 10 mIU/mL had premature luteinization indicated by a serum progesterone above 2 ng/mL. A multicenter, open-label, randomized study was conducted to assess the efficacy and safety of Ganirelix Acetate Injection in women undergoing COH. Follicular phase treatment with Ganirelix Acetate 250 mcg was studied using a luteal ph… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 58 words ▾

Carcinogenesis and Mutagenesis, Impairment of Fertility Long-term toxicity studies in animals have not been performed with Ganirelix Acetate Injection to evaluate the carcinogenic potential of the drug. Ganirelix Acetate did not induce a mutagenic response in the Ames test (S. typhimurium and E. coli ) or produce chromosomal aberrations in in vitro assay using Chinese Hamster Ovary cells.

📄 Package Label / Principal Display Panel 112 words ▾

PRINCIPAL DISPLAY PANEL - 250 mcg/0.5 mL Syringe Blister Pack Carton NDC 78206-138-01 250 mcg Single-dose Sterile Prefilled Syringe 27 gauge by 1/2" needle Ganirelix Acetate Injection 250 mcg/0.5 mL For Subcutaneous Use Rx only Caution: The needle cover contains dry natural rubber/latex which comes into contact with this product and may cause allergic reactions. PRINCIPAL DISPLAY PANEL - 250 mcg/0.5 mL Syringe Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 250 mcg/0.5 mL Syringe Blister Pack Carton NDC 78206-138-02 250 mcg Single-dose Sterile Prefilled Syringe 27 gauge by 1/2" needle Ganirelix Acetate Injection 250 mcg/0.5 mL For Subcutaneous Use Rx only PRINCIPAL DISPLAY PANEL - 250 mcg/0.5 mL Syringe Blister Pack Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ganirelix Acetate — the ingredient across all brands.

Top reported reactions

Ovarian Hyperstimulation Syndrome253
Ascites58
Nausea37
Dyspnoea34
Abdominal Pain28
Headache26
Pleural Effusion22

Age at onset

Adult98

Reporter sex

639 reports
Male · 1%
Female · 99%
Unknown · 0%

Serious outcomes

Disabling4
Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 116 21
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Organon LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 syringe (78206-0138-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Organon LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3490 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 78206-0137-01 · Organon 78206-0139-01 · Organon →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.