Chorionic Gonadotropin Kit — NDC 63323-030-11 (Billing 63323-0030-11)
This is a package of Chorionic Gonadotropin Kit from Fresenius Kabi USA, LLC, marketed since Apr 2011 and currently FDA-listed; retail pharmacies pay about $253.05 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 63323-030-11 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63323 labeler · 030 product · 11 package
- Package marketed since
- Apr 21, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0363323030100, 0363323950019, 0363323030117
- Medicaid fills, this package
- 1,564 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): 003173
- GCN: 10490
- GPI-14 (Medi-Span): 30062020002140
- HICL (First Databank): 001408
- AHFS class code: 68:18.08.00
- RxCUI (RxNorm): 896854
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 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 8, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 | $253.048 | — |
| Medicaid paysCMS SDUD · 12 mo | $212.49 | — |
| 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 Q1 2026
- 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 |
|---|---|---|---|---|
| 63323-0030-11 You're viewing this Main listing | 1 KIT in 1 CARTON * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL, MULTI-DOSE | 2011-04-21 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pregnyl 78206-0150-01 | Organon | 1 kit | $171.530 | — | Availability likely | save 32% |
| Chorionic Gonadotropinthis 63323-0030-11 | Fresenius | 1 kit | $253.048 | — | Availability likely | — |
| Pregnyl 50090-7089-00 | A-S | 1 kit | — | — | FDA listed | — |
| Chorionic Gonadotropin 68071-3815-01 | NuCare | 1 kit | — | — | FDA listed | — |
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 8, 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 Fresenius Kabi USA, LLC labeler code 63323
- Gentamicin 40 mg/mL Injection, Solution NDC 63323-010-02
- Chloramphenicol Sodium Succinate 1 g/10mL Injection, Powder, Lyophilized, For Solution NDC 63323-011-15
- Oxytocin 10 [USP'U]/mL Injection, Solution NDC 63323-012-01
- Thiamine 100 mg/mL Injection, Solution NDC 63323-013-02
- Mannitol 250 mg/mL Injection, Solution NDC 63323-024-25
- SODIUM ACETATE 4 meq/100mL Injection, Solution, Concentrate NDC 63323-032-00
- Cyanocobalamin 1000 ug/mL Injection, Solution NDC 63323-044-01
- Heparin Sodium 5000 [USP'U]/mL Injection, Solution NDC 63323-047-10
- Magnesium Sulfate 500 mg/mL Injection, Solution NDC 63323-064-02
- Sodium Bicarbonate 42 mg/mL Injection, Solution NDC 63323-083-05
- Sodium Chloride 234 mg/mL Injection, Solution NDC 63323-088-61
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. 1.
Prepubertal cryptorchidism not due to anatomical obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help 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 four and nine. 2.
Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. 3. 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 1.
4,000 USP units three times weekly for three weeks. 2. 5,000 USP units every second day for four injections.
3. 15 injections of 500 to 1,000 USP units over a period of six weeks. 4.
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 1.
500 to 1,000 USP units three times a week for three weeks, followed by the same dose twice a week for three weeks. 2. 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.
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.) IMPORTANT: USE COMPLETELY WITHIN 60 DAYS AFTER RECONSTITUTION.
REFRIGERATE AFTER RECONSTITUTION.
⛔ Contraindications ▾
CONTRAINDICATIONS: Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.
⚠️ 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 are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births and (4) Arterial thromboembolism.
Anaphylaxis and other hypersensitivity reactions have been reported with urinary-derived HCG products.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Chorionic gonadotropin may interfere with radioimmunoassay for gonadotropins, particularly luteinizing hormone.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects: Chorionic gonadotropin may cause fetal harm when administered to a pregnant woman. Defects of forelimbs and central nervous system and alterations in sex ratio have been reported in mice receiving combined gonadotropin and chorionic gonadotropin therapy in dosages to induce superovulation. Multiple ovulations with resulting plural gestations (mostly twins) have been reported to occur in approximately 20% of pregnancies when conception has followed chorionic gonadotropin therapy.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of chorionic gonadotropin in children below the age of four 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: Chorionic Gonadotropin, lyophilized powder, is supplied in two-vial packages including Bacteriostatic Water for Injection as diluent as follows: Product Code Unit of Sale Description 325011 NDC 63323-030-11 One carton containing Chorionic Gonadotropin, 10,000 USP units per vial in a 10 mL multiple dose vial (NDC 63323-030-10) with accompanying diluent (NDC 63323-950-01). Store at room temperature 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. If needed, the reconstituted vial may be refrigerated between 2℃ to 8℃ (36℉ to 46℉) and must be discarded after 60 days.
Do not freeze and do not shake. Manufactured by: www.fresenius-kabi.com/us US License Number 2146 45792J Revised: February 2025 chori-img-01.jpg
📋 Description ▾
DESCRIPTION: Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta sub-unit. The alpha sub-unit is essentially identical to the alpha sub-units of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha sub-unit of human thyroid-stimulating hormone (TSH). The beta sub-units of these hormones differ in amino acid sequence.
Chorionic gonadotropin is obtained from the human pregnancy urine. It is standardized by a biological assay procedure. Chorionic Gonadotropin for injection is a sterile lyophilized powder available in multiple dose vials containing 10,000 USP units to be reconstituted with accompanying Bacteriostatic Water for Injection and administered intramuscularly after reconstitution.
When reconstituted with 10 mL of the accompanying diluent each vial contains: Chorionic gonadotropin 10,000 USP units benzyl alcohol 0.9% dibasic sodium phosphate 13 mg mannitol 100 mg monobasic sodium phosphate 3 mg water for injection q.s. Buffered with dibasic sodium phosphate and monobasic sodium phosphate. Hydrochloric acid and/or sodium hydroxide may have been used for pH adjustment (6.0-8.0).
Nitrogen gas is used in the freeze drying process.
⚠️ 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 Interactions Chorionic gonadotropin may interfere with radioimmunoassay for gonadotropins, particularly luteinizing hormone. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of chorionic gonadotropin. Pediatric Use Safety and effectiveness of chorionic gonadotropin in children below the age of four have not been established.
Pregnancy Teratogenic Effects: Chorionic gonadotropin may cause fetal harm when administered to a pregnant woman. Defects of forelimbs and central nervous system and alterations in sex ratio have been reported in mice receiving combined gonadotropin and chorionic gonadotropin therapy in dosages to induce superovulation. Multiple ovulations with resulting plural gestations (mostly twins) have been reported to occur in approximately 20% of pregnancies when conception has followed chorionic gonadotropin therapy.
Nursing Mothers It is not known whether chorionic gonadotropin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when chorionic gonadotropin is administered to a nursing woman.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether chorionic gonadotropin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when chorionic gonadotropin is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of chorionic gonadotropin.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – PRINCIPAL DISPLAY – Chorionic Gonadotropin 10 mL Multiple Dose Vial Label NDC 63323-030-10 Chorionic Gonadotropin for Injection 10,000 USP units per vial For intramuscular use only. Multiple Dose Vial Rx only chori-label-01.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY - Bacteriostatic Water 10 mL Multiple Dose Vial Label Bacteriostatic Water for Injection, USP NOT FOR USE IN NEWBORNS. 10 mL Multiple Dose Vial Rx only chori-label-02.jpg
PACKAGE LABEL – PRINCIPAL DISPLAY – Chorionic Gonadotropin 10 mL Multiple Dose Vial Carton Panel NDC 63323-030-11 Chorionic Gonadotropin for Injection 10,000 USP units per vial For intramuscular use only. With Bacteriostatic Water for Injection, USP as diluent. Rx only One multiple-dose vial containing chorionic gonadotropin and One multiple-dose vial of diluent 10 mL Multiple Dose Vials chori-label-03.jpg
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 |