Novarel gonadotrophin, chorionic Kit — NDC 55566-1502-1 (Billing 55566-1502-01)
This is a package of Novarel gonadotrophin, chorionic Kit from Ferring Pharmaceuticals Inc., marketed since Aug 2017 and currently FDA-listed; retail pharmacies pay about $171.65 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 55566-1502-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 55566 labeler · 1502 product · 1 package
- Package marketed since
- Aug 30, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 5556615021 9
- Medicaid fills, this package
- 67 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003176
- GCN: 10496
- GPI-14 (Medi-Span): 30062020002130
- HICL (First Databank): 001408
- AHFS class code: 68:18.08.00
- RxCUI (RxNorm): 310587
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Gonadotropin class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $171.647 | — |
| Medicaid paysCMS SDUD · 12 mo | $163.32 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0725 | $15.069 / J0725 unit | — |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 55566-1502-01 You're viewing this Main listing | 1 KIT in 1 CARTON * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL | 2017-08-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Novarelthis 55566-1502-01 | Ferring | 1 kit | $171.647 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Ferring Pharmaceuticals Inc. labeler code 55566
- Fyremadel ganirelix acetate 250 ug/.5mL Injection, Solution NDC 55566-1010-1
- ADSTILADRIN nadofaragene firadenovec-vncg 300000000000 {VP}/mL Suspension NDC 55566-1050-1
- ZOMACTON somatropin Kit NDC 55566-1801-1
- ZOMACTON somatropin Kit NDC 55566-1901-1
- DDAVP Desmopressin Acetate 4 ug/mL Injection NDC 55566-2200-0
- DDAVP Desmopressin Acetate 4 ug/mL Injection NDC 55566-2300-0
- DDAVP Desmopressin Acetate .1 mg Tablet NDC 55566-2600-0
- DDAVP Desmopressin Acetate .2 mg Tablet NDC 55566-2700-0
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. Prepubertal cryptorchidism not due to anatomic obstruction.
In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary.
Therapy is usually instituted between the ages of 4 and 9. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION (Intramuscular Use Only): The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patient, and the physician's preference. The following regimens have been advocated by various authorities. Prepubertal cryptorchidism not due to anatomical obstruction: 4,000 USP Units three times weekly for three weeks.
5,000 USP Units every second day for four injections. 15 injections of 500 to 1,000 USP Units over a period of six weeks. 500 USP Units three times weekly for four to six weeks.
If this course of treatment is not successful, another is begun one month later, giving 1,000 USP Units per injection. Selected cases of hypogonadotropic hypogonadism in males: 500 to 1,000 USP Units three times a week for three weeks, followed by the same dose twice a week for three weeks. 4,000 USP Units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP Units three times weekly for an additional three months.
Table 1. Final Concentration after Reconstitution Reconstitution volume of bacteriostatic water for injection 10,000 IU Vial Concentration 5,000 IU Vial Concentration Administration 1 mL 10,000 IU/mL 5,000 IU/mL Administer entire dose at once 10 mL 1,000 IU/mL 500 IU/mL Multiple dose administration, refrigerate between doses NOTE: Prior to diluting NOVAREL with Bacteriostatic Water for Injection (Table 1): Remove the flip caps off the vial of bacteriostatic water and the vial of NOVAREL Wipe the tops of the vials with an alcohol pad or alcohol soaked gauze Do not touch the tops of the vials after you wipe them.
Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with human menotropins (See prescribing information for menotropins for dosage and administration for that drug product). 5,000 to 10,000 USP Units one day following the last dose of menotropins. (A dosage of 10,000 USP Units is recommended in the labeling for menotropins).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Disposing of Needles and Syringes To safely dispose of medical sharps, place used needles and syringes in a closeable, puncture-resistant container, such as a red biohazard sharps container. Sharps containers should then be taken to a collection center for proper disposal.
Ask your physician or pharmacist or reference our website for more information about safely disposing used sharps. In some states, it is illegal to throw away medical sharps in household garbage, recycling, and compost bins. Needles and other sharps must be placed in an approved sharps container and disposed of at an approved drop-off site.
⛔ Contraindications ▾
CONTRAINDICATIONS Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman. Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.
⚠️ Warnings ▾
WARNINGS HCG should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions during this use are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion; (2) Enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum; (3) Multiple births, and (4) Arterial thromboembolism.
The recommended diluent for reconstitution is Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Anaphylaxis has been reported with urinary-derived HCG products.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS (see WARNINGS ) Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection. Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported. The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory test HCG can crossreact in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of crossreactivity with their gonadotropin assay. Physicians should make the laboratory aware of patients on HCG if gonadotropin levels are requested.
🤰 Pregnancy ▾
Pregnancy See " CONTRAINDICATIONS " section. Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children below the age of 4 have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone. Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present.
This descent is usually reversible when HCG is discontinued. During the normal menstrual cycle, LH participates with FSH in the development and maturation of the normal ovarian follicle, and the mid-cycle LH surge triggers ovulation. HCG can substitute for LH in this function.
During a normal pregnancy, HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued secretion of estrogen and progesterone, and preventing menstruation. HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED NOVAREL (chorionic gonadotropin) for Injection, USP, is available as individually packaged multiple-dose vials containing 5,000 or 10,000 USP Units per vial. Each vial of NOVAREL is accompanied by a vial of sterile diluent containing 10 mL of Bacteriostatic Water for Injection, USP containing 0.9% benzyl alcohol. NOVAREL is available in the following presentations: NDC 55566-1501-1 : 10,000 USP units of chorionic gonadotropin injection in 1 vial with blue cap and 1 vial of diluent NDC 55566-1502-1 : 5,000 USP units of chorionic gonadotropin injection in 1 vial with aqua cap and 1 vial of diluent Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [See USP Controlled Room Temperature].
REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.
📦 Storage and Handling ▾
Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [See USP Controlled Room Temperature]. REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.
📋 Description ▾
DESCRIPTION Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence.
NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days.
Each 5,000 USP units vial contains: chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains: chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.
⚠️ Precautions ▾
PRECAUTIONS General Induction of androgen secretion by HCG may induce precocious puberty in patients treated for cryptorchidism. Therapy should be discontinued if signs of precocious puberty occur. Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.
Drug/Laboratory test HCG can crossreact in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of crossreactivity with their gonadotropin assay. Physicians should make the laboratory aware of patients on HCG if gonadotropin levels are requested.
Carcinogenesis, Mutagenesis, Impairment of Fertility There have been sporadic reports of testicular tumors in otherwise healthy young men receiving HCG for secondary infertility. A causative relationship between HCG and tumor development in these men has not been established. Defects of forelimbs and of the central nervous system, as well as alterations in sex ratio, have been reported in mice on combined gonadotropin and HCG regimens.
The dose of gonadotropin used was intended to induce superovulation. No mutagenic effect has been clearly established in humans. Fertility—see " INDICATIONS AND USAGE ." Pregnancy See " CONTRAINDICATIONS " section.
Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined. Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when HCG is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 4 have not been established.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HCG is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility There have been sporadic reports of testicular tumors in otherwise healthy young men receiving HCG for secondary infertility. A causative relationship between HCG and tumor development in these men has not been established. Defects of forelimbs and of the central nervous system, as well as alterations in sex ratio, have been reported in mice on combined gonadotropin and HCG regimens.
The dose of gonadotropin used was intended to induce superovulation. No mutagenic effect has been clearly established in humans. Fertility—see " INDICATIONS AND USAGE ."
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - Kit Carton - 5,000 USP NDC 55566-1502-1 Rx only chorionic gonadotropin Novarel ® for injection 5,000 USP units for intramuscular use only 1 multiple-dose vial of Chorionic Gonadotropin for Injection 1 multiple-dose vial of Bacteriostatic Water for injection, USP, 10 mL FERRING PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - Kit Carton - 5,000 USP
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |