🆔 Identity & classification

FDA NDC (as labeled) 44087-1150-1

Product NDC 44087-1150

11-digit billing NDC 44087115001

NCPDP billing unit ML — per mL (volume)

RxCUI 727505, 727507

UNII 6413W06WR3

Application # BLA021149

SPL Set ID a683e58a-63ea-44b8-a326-1a99a537bcf2

Established class (EPC) Gonadotropin

Chemical class Gonadotropins

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2003-10-06

Route SUBCUTANEOUS

Dosage form INJECTION, SOLUTION

Substance CHORIOGONADOTROPIN ALFA

GPI-14 3006202205E520

GPI class Ovidrel

GCN Seq No 053123

GCN 20473

HICL code 021868

Ingredient (HICL) Choriogonadotropin Alfa

HIC1 code P

Therapeutic class — broad (HIC1) Endocrine System

HIC2 code P0

Therapeutic class — intermediate (HIC2) Ovulation Stimulants/Pregnancy Facilitators

HIC3 code P0D

Therapeutic class — specific (HIC3) Human Chorionic Gonadotropin (Hcg)

AHFS code 68:18.08.00

AHFS class Gonadotropins

FDB label name OVIDREL 250 MCG/0.5 ML SYRG

FDB brand name Ovidrel

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 44087-1150-1 — a 5-4-1 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 package segment → 44087-1150-01. 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 class.

Pharmacologic class Gonadotropin

Drug family (ATC) Gonadotropins

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.

🏭 Manufacturer & labeler

LabelerEMD Serono, Inc.

FDA applicationBLA021149 (BLA)

Labeler code44087

First marketedOct 2003

Product typeHuman Prescription Drug

Portfolio18 products on file

🔎 All NDCs from EMD Serono, Inc.

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.

🩺 Clinical

Label name OVIDREL 250 MCG/0.5 ML SYRG Ingredient Choriogonadotropin Alfa

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

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 AE28F7PNPL
Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
UNII LQA7B6G8JG
A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
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.

6 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.

💲 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$485.508	$242.75 / 0.5 ml
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.

NADAC price history (per mL) — tap or hover for the price & month

▲ Up 32% over the last 11 months.

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)44087-1150-1

11-digit billing NDC44087-1150-01

Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)

HCPCS J-codeJ3490

DescriptorUNCLASSIFIED DRUGS

Billing units / pkg1 units

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ovidrel 250 ug/.5mLthis 44087-1150-01	EMD	1 syringe	$485.508	—	Availability likely	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

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 & biosimilar status

🏛️

2000

First FDA approval

Sep 2000

📍

2026

Currently FDA-listed

26 years listed

🧬

·

Biosimilars

see Purple Book

🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Ovidrelchoriogonadotropin alfa

🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

Where does this data come from?

Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🔬 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 Ovidrel (this brand).

Top reported reactions

Ovarian Hyperstimulation Syndrome433

Ascites81

Abdominal Distension68

Abdominal Pain67

Nausea57

Dyspnoea50

Pleural Effusion48

Age at onset

Neonate4

Adolescent6

Adult349

Elderly3

Reporter sex

Male · 4%

Female · 96%

Unknown · 1%

Serious outcomes

Hospitalization561

Life-threatening46

Death24

Disabling14

Reports over time (by year) — tap or hover for the count & year

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
44087-1150-01 You're viewing this	1 SYRINGE, GLASS in 1 CARTON (44087-1150-1) / .5 mL in 1 SYRINGE, GLASS	2003-10-06	Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 220 words ▾

INDICATIONS AND USAGE Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel ® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Selection of Patients Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel ® PreFilled Syringe only if enrolled in an in vitro fertilization program.

Primary ovarian failure should be excluded by the determination of gonadotropin levels. Appropriate evaluation should be performed to exclude pregnancy. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders.

A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel ® PreFilled Syringe therapy. Evaluation of the partner's fertility potential should be included in the initial evaluation.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION For Subcutaneous Use Only Infertile Women Undergoing Assisted Reproductive Technologies (ART) Ovidrel ® PreFilled Syringe 250 µg should be administered one day following the last dose of the follicle stimulating agent. Ovidrel ® PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Administration should be withheld in situations where there is an excessive ovarian response, as evidenced by clinically significant ovarian enlargement or excessive estradiol production.

Infertile Women Undergoing Ovulation Induction (OI) Ovidrel ® PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Ovidrel ® PreFilled Syringe 250 µg should be administered one day following the last dose of the follicle stimulating agent. Ovidrel ® PreFilled Syringe administration should be withheld in situations where there is an excessive ovarian response, as evidenced by multiple follicular development, clinically significant ovarian enlargement or excessive estradiol production.

Directions for Administration of Ovidrel ® Prefilled Syringe Ovidrel ® PreFilled Syringe is intended for a single subcutaneous injection. Any unused material should be discarded. Ovidrel ® PreFilled Syringe may be self-administered by the patient.

Follow the directions below for injecting Ovidrel ® PreFilled Syringe. Step 1: Wash your hands thoroughly with soap and water. Step 2: Carefully clean the injection site.

Make yourself comfortable by sitting or lying down. Carefully clean the injection site on the stomach with an alcohol wipe and allow it to air-dry. Step 3: Administer your injection.

Carefully remove the needle cap from the syringe. Do not touch the needle or allow the needle to touch any surface. Inject the prescribed dose as directed by your doctor, nurse or pharmacist.

Step 4: Gently withdraw the needle. Discard the needle and syringe into your safety container. Place gauze over the injection site.

If any bleeding occurs, apply gentle pressure. If bleeding does not stop within a few minutes, place a clean piece of gauze over the injection site and cover it with an adhesive bandage. Step 5: Storage and clean up.

Remember that your injection materials must be kept sterile and cannot be reused. Figure 1 Figure 2

⛔ Contraindications 81 words ▾

CONTRAINDICATIONS Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is contraindicated in women who exhibit: Prior hypersensitivity to hCG preparations or one of their excipients. Primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction.

An uncontrolled organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see " Selection of Patients " ). Ovarian cyst or enlargement of undetermined origin (see " Selection of Patients " ).

Sex hormone dependent tumors of the reproductive tract and accessory organs. Pregnancy.

⚠️ Warnings ~3 min read ▾

WARNINGS Gonadotropins, including Ovidrel ® PreFilled Syringe (choriogonado-tropin alfa injection), should only be used by physicians who are thoroughly familiar with infertility problems and their management. Like other hCG products, Ovidrel ® PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. The risks of gonadoptropin treatment should be considered for women with risk factors of thromboembolic events such as prior medical or family history.

Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see " Precautions/ Laboratory Tests "). Safe and effective induction of ovulation and use of Ovidrel ® PreFilled Syringe in women requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis. Overstimulation of the Ovary Following hCG Therapy Ovarian Enlargement Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distention and/or abdominal pain may occur in patients treated with FSH and hCG, and generally regresses without treatment within two or three weeks.

Careful monitoring of ovarian response can further minimize the risk of overstimulation. If the ovaries are abnormally enlarged on the last day of FSH therapy, choriogonadotropin alfa should not be administered in this course of therapy. This will reduce the risk of development of Ovarian Hyperstimulation Syndrome.

Ovarian Hyperstimulation Syndrome (OHSS) OHSS is a medical event distinct from uncomplicated ovarian enlargement. Severe OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event. It is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium.

The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. The following symptomatology has been seen with cases of OHSS: abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events (see " Pulmonary and Vascular Complications ").

Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with Ovarian Hyperstimulation Syndrome (OHSS). OHSS occurred in 4 of 236 (1.7 %) patients treated with Ovidrel ® 250 µg during clinical trials for ART and 3 of 99 (3.0%) patients treated in the OI trial. OHSS occurred in 8 of 89 (9.0%) patients who received Ovidrel ® 500 µg.

Two patients treated with Ovidrel ® 500 µg developed severe OHSS. OHSS may be more severe and more protracted if pregnancy occurs. OHSS develops rapidly; therefore, patients should be followed for at least two weeks after hCG administration.

Most often, OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration (see " Precautions/Laboratory Tests "), the hCG must be withheld.

If severe OHSS occurs, treatment with gonadotropins must be stopped and the patient should be hospitalized. A physician experienced in the management of this syndrome, or who is experienced in the management of fluid and electrolyte imbalances should be consulted. Multiple Births As with other hCG products, reports of multiple births have been associated…

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS (see WARNINGS ) The safety of Ovidrel ® was examined in four clinical studies that treated 752 patients of whom 335 received Ovidrel ® 250 µg following follicular recruitment with gonadotropins. When patients enrolled in four clinical studies (3 in ART and one in OI) were injected subcutaneously with either Ovidrel ® or an approved urinary-derived hCG, 14.6 % (49 of 335 patients) in the Ovidrel ® 250 µg group experienced application site disorders compared to 28% (92 of 328 patients) in the approved u-hCG group.

Adverse events reported for Ovidrel ® 250 µg occurring in at least 2% of patients (regardless of causality) are listed in Table 9 for the 3 ART studies and in Table 10 for the single OI study. Table 9: Incidence of Adverse Events of r-hCG in ART (Studies 7648, 7927, 9073) Body System Ovidrel ® 250 µg (n=236) Preferred Term Incidence Rate % (n) At Least One Adverse Event 33.1% (78) Application Site Disorders 14.0% (33) Injection Site Pain 7.6% (18) Injection Site Bruising 4.7% (11) Gastro-Intestinal System Disorders 8.5% (20) Abdominal Pain 4.2% (10) Nausea 3.4% ( 8) Vomiting 2.5% ( 6) Secondary Terms (Post-Operative Pain) 4.7% (11) Post-Operative Pain 4.7% (11) Adverse events not listed in Table 9 that occurred in less than 2% of patients treated with Ovidrel ® 250 µg whether or not considered causally related to Ovidrel ® , included: injection site inflammation and reaction, flatulence, diarrhea, hiccup, ectopic pregnancy, breast pain, intermenstrual bleeding, vaginal hemorrhage, cervical lesion, leukorrhea, ovarian hyperstimulation, uterine disorders, vaginitis, vaginal discomfort, body pain, back pain, fever, dizziness, headache, hot flashes, malaise, paraesthesias, rash, emotional lability, insomnia, upper respiratory tract infection, cough, dysuria, urinary tract infection, urinary incontinence, albuminuria, cardiac arrhythmia, genital moniliasis, genital herpes, leukocytosis, heart murmur and cervical carcinoma.

Table 10: Incidence of Adverse Events of r-hCG in Ovulation Induction (Study 8209) Body System Ovidrel ® 250 µg (n=99) Preferred Term Incidence Rate % (n) At Least One Adverse Event 26.2% (26) Application Site Disorders 16.2% (16) Injection site pain 8.1% (8) Injection site inflammation 2.0% (2) Injection site bruising 3.0% (3) Injection site reaction 3.0% (3) Reproductive Disorders, Female 7.1% (7) Ovarian cyst 3.0% (3) Ovarian hyperstimulation 3.0% (3) Gastro-Intestinal System Disorders 4.0% (4) Abdominal pain 3.0% (3) Additional adverse events not listed in Table 10 that occurred in less than 2% of patients treated with Ovidrel ® 250 µg, whether or not considered causally related to Ovidrel ® , included: breast pain, flatulence, abdominal enlargement, pharyngitis, upper respiratory tract infection, hyperglycemia and pruritis.

The following medical events have been reported subsequent to pregnancies resulting from hCG therapy in controlled clinical studies: Spontaneous Abortion Ectopic Pregnancy Premature Labor Postpartum Fever Congenital Abnormalities Of 125 clinical pregnancies reported following treatment with FSH and Ovidrel ® 250 µg or 500 µg, three were associated with a congenital anomaly of the fetus or newborn. Among patients receiving Ovidrel ® 250 µg, cranial malformation was detected in the fetus of one woman and a chromosomal abnormality (47, XXX) in another.

These events were judged by the investigators to be of unlikely or unknown relation to treatment. These three events represent an incidence of major congenital malformations of 2.4%, which is consistent with the reported rate for pregnancies resulting from natural or assisted conception. In a woman who received Ovidrel ® 500 µg, one birth in a set of triplets was associated with Down's syndrome and atrial septal defect.

This event was considered to be unrelated to the study drug. The following adverse reactions have been previously reported during menotropin therapy: Pulmonary and vascular complications (see " Warning…

🤰 Pregnancy 34 words ▾

Pregnancy Intrauterine death and impaired parturition were observed in pregnant rats given a dose of urinary-hCG (500 IU) equivalent to three times the maximum human dose of 10,000 USP, based on body surface area.

🧒 Pediatric Use 12 words ▾

Pediatric Patients Safety and effectiveness in pediatric patients has not been established.

🧓 Geriatric Use 12 words ▾

Geriatric Patients Safety and effectiveness in geriatric patients has not been established.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY The physicochemical, immunological, and biological activities of recombinant hCG are comparable to those of placental and human pregnancy urine-derived hCG. Choriogonadotropin alfa stimulates late follicular maturation and resumption of oocyte meiosis, and initiates rupture of the pre-ovulatory ovarian follicle. Choriogonadotropin alfa, the active component of Ovidrel ® PreFilled Syringe , is an analogue of Luteinizing Hormone (LH) and binds to the LH/hCG receptor of the granulosa and theca cells of the ovary to effect these changes in the absence of an endogenous LH surge.

In pregnancy, hCG, secreted by the placenta, maintains the viability of the corpus luteum to provide the continued secretion of estrogen and progesterone necessary to support the first trimester of pregnancy. Ovidrel ® PreFilled Syringe is administered when monitoring of the patient indicates that sufficient follicular development has occurred in response to FSH treatment for ovulation induction. Pharmacokinetics When given by intravenous administration, the pharmacokinetic profile of Ovidrel ® followed a biexponential model and was linear over a range of 25 µg to 1000 µg.

Pharmacokinetic parameter estimates following SC administration of Ovidrel ® 250 µg to females are presented in Table 1. Table 1: Pharmacokinetic Parameters (mean ± SD) of r-hCG after Single-Dose Administration of Ovidrel ® in Healthy Female Volunteers Ovidrel ® 250 µg SC C max : peak concentration (above baseline), t max : time of C max , AUC: total area under the curve, t ½ : elimination half-life, F: bioavailability C max (IU/L) 121 ± 44 t max (h) median (range) 24 (12-24) AUC (h∙IU/L) 7701 ± 2101 t ½ (h) 29 ± 6 F 0.4 ±

0.1Absorption Following subcutaneous administration of Ovidrel ® 250 µg, maximum serum concentration (121 ± 44 IU/L) is reached after approximately 12 to 24 hours. The mean absolute bioavailability of Ovidrel ® following a single subcutaneous injection to healthy female volunteers is about 40%. Distribution Following intravenous administration of Ovidrel ® 250 µg to healthy down-regulated female volunteers, the serum profile of hCG is described by a two-compartment model with an initial half-life of 4.5 ± 0.5 hours.

The volume of the central compartment is 3.0 ±

0.5L and the steady state volume of distribution is 5.9 ±

1.0L. Metabolism/Excretion Following subcutaneous administration of Ovidrel ® , hCG is eliminated from the body with a mean terminal half-life of about 29 ± 6 hours. After intravenous administration of Ovidrel ® 250 µg to healthy down-regulated females, the mean terminal half-life is 26.5 ± 2.5 hours and the total body clearance is 0.29 ±

0.04L/h. One-tenth of the dose is excreted in the urine. Pharmacodynamics In female subjects on oral contraception after an initial latency period, Ovidrel ® induced a clear increase in androstenedione serum levels by 24 hours after dosing.

Pharmacodynamic studies in females determined that the relationship of Ovidrel ® pharmacokinetics to pharmacologic effect of Ovidrel ® are complex and vary with the pharmacodynamic marker examined. In general pharmacologic effects are not proportional to exposure and in some cases appear to be near maximal at a 250 µg dose. Population pharmacokinetics and pharmacodynamics In patients undergoing in-vitro fertilization/embryo transfer given Ovidrel ® subcutaneously to trigger ovulation, the results of a population PK/PD analysis generally supported the data obtained in healthy subjects.

Pharmacokinetic parameters for Ovidrel ® include a median elimination half-life of 29.2 hours, median apparent clearance (Cl/F) of

0.51 L/hr and median apparent volume of distribution (V/F) of

21.4L. Bioequivalence of Formulations Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) has been determined to be bioequivalent to Ovidrel ® (choriogonadotropin alfa for injection) based on the statistical evaluation of AUC and C max . A summary of the Ovidrel ® PreFilled Sy…

📦 How Supplied / Storage and Handling 174 words ▾

HOW SUPPLIED Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is supplied in a sterile, liquid single dose pre-filled 1 mL syringe. Each Ovidrel ® PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL. The following package combination is available: 1 pre-filled syringe containing 250 μg Ovidrel ® PreFilled Syringe NDC 44087-1150-1 Storage The Ovidrel ® PreFilled Syringe must be stored refrigerated between 2-8°C (36-46°F) before being dispensed to the patient.

Patients should store the pre-filled syringe refrigerated to allow the product to be used until the expiry date shown on the syringe or carton. The Ovidrel ® PreFilled Syringe may be stored by the patient for no more than 30 days at room temperature (up to 25°C (77°F) but must be used within those 30 days. Protect from light.

Store in original package. Discard unused material.

📦 Storage and Handling 85 words ▾

Storage The Ovidrel ® PreFilled Syringe must be stored refrigerated between 2-8°C (36-46°F) before being dispensed to the patient. Patients should store the pre-filled syringe refrigerated to allow the product to be used until the expiry date shown on the syringe or carton. The Ovidrel ® PreFilled Syringe may be stored by the patient for no more than 30 days at room temperature (up to 25°C (77°F) but must be used within those 30 days.

Protect from light. Store in original package. Discard unused material.

📋 Description ~2 min read ▾

DESCRIPTION Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein consisting of two non-covalently linked subunits - designated α and β - consisting of 92 and 145 amino acid residues, respectively, with carbohydrate moieties linked to ASN-52 and ASN-78 (on alpha subunit) and ASN-13, ASN-30, SER-121, SER-127, SER-132 and SER-138 (on beta subunit).

The primary structure of the α - chain of r-hCG is identical to that of the α - chain of hCG, FSH and LH. The glycoform pattern of the α - subunit of r-hCG is closely comparable to urinary derived hCG (u-hCG), the differences mainly being due to the branching and sialylation extent of the oligosaccharides. The β - chain has both O- and N-glycosylation sites and its structure and glycosylation pattern are also very similar to that of u-hCG.

The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Choriogonadotropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. This process yields a product with a high level of purity and consistent product characteristics including glycoforms and biological activity.

The biological activity of choriogonadotropin alfa is determined using the seminal vesicle weight gain test in male rats described in the "Chorionic Gonadotrophins" monograph of the European Pharmacopoeia. The in vivo biological activity of choriogonadotropin alfa has been calibrated against the third international reference preparation IS75/587 for chorionic gonadotropin. Ovidrel ® PreFilled Syringe is a sterile, liquid intended for subcutaneous (SC) injection.

Each Ovidrel ® PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL. The pH of the solution is 6.5 to 7.5. Therapeutic Class: Infertility

💬 Information for Patients 54 words ▾

Information for Patients Prior to therapy with hCG, patients should be informed of the duration of treatment and monitoring of their condition that will be required. The risks of ovarian hyperstimulation syndrome and multiple births in women (see WARNINGS ) and other possible adverse reactions (see " Adverse Reactions ") should also be discussed.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal distension: A swollen or stretched feeling in the belly, often from gas or fluid.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

albuminuria: Albumin, a protein from the blood, leaking into the urine; it is a common early sign of kidney damage.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

ascites: A buildup of fluid inside the belly.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bioequivalence: A measure showing two versions of a medicine deliver the same amount of drug into the body at the same rate.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

congenital anomaly: A physical difference or defect that a baby is born with, present from before birth.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

desensitization: A medical process of giving tiny, slowly increasing doses to help the body tolerate a substance it reacts to.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

dysuria: Pain, burning, or discomfort when passing urine.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emotional lability: Rapid, exaggerated mood changes that shift quickly from one feeling to another.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fertility: The natural ability to become pregnant or to father a child.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

injection site reaction: Redness, swelling, pain, or itching in the spot where a shot was given.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

leukocytosis: A higher-than-normal level of white blood cells, often a sign the body is fighting an infection.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

oliguria: Producing much less urine than normal, which is often a sign the kidneys are under stress.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

postpartum: The period of time right after a woman gives birth.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

spontaneous abortion: The natural loss of a pregnancy in its early stages, also called a miscarriage.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

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

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🧪 All Choriogonadotropin Alfa NDCsSame ingredient 🏭 All EMD labeler NDCsLabeler code 44087 📚 All Gonadotropin NDCsDrug class 🧾 J3490 billing & NDC crosswalkJ-code

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Chorionic Gonadotropin, Human 00052-0315-10

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Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Ovidrel choriogonadotropin alfa 250 ug/.5mL Injection, Solution, 1 syringe

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0.51 L/hr and median apparent volume of distribution (V/F) of

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