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Chorionic Gonadotropin Kit — NDC 63323-0030-11 package photo

Chorionic Gonadotropin Kit

by Fresenius Kabi USA, LLC · 1 KIT in 1 CARTON (63323-030-11) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL, MULTI-DOSE
NDC 63323-0030-11
🏷️ FDA NDC (as labeled) 63323-030-11 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 63323-030-11
Product NDC 63323-030
11-digit billing NDC 63323003011
NCPDP billing unit EA — each (per item)
RxCUI 896854
UPC 0363323030100, 0363323950019, 0363323030117
Application # BLA017067
SPL Set ID f93b2baa-03ac-4650-b35a-20b818d712d6
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-04-21
Dosage form KIT
GPI-14 30062020002140
GPI class Chorionic Gonadotropin
GCN Seq No 003173
GCN 10490
HICL code 001408
Ingredient (HICL) Chorionic Gonadotropin, Human
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 CHORIONIC GONAD 10,000 UNIT VL
FDB brand name Chorionic Gonadotropin
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 63323-030-11 — 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 → 63323-0030-11. 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

LabelerFresenius Kabi USA, LLC
FDA applicationBLA017067 (BLA)
Labeler code63323
First marketedApr 2011
Product typeHuman Prescription Drug
Portfolio554 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.

🩺 Clinical

Label name CHORIONIC GONAD 10,000 UNIT VL Ingredient Chorionic Gonadotropin, Human

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $251.584 —
Medicaid paysCMS SDUD · 12 mo $269.65 —
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 —
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Jan 2026 Jun 2026 Aug 2026 $285.763 $250.670
Flat over the last 6 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)63323-030-11
11-digit billing NDC63323-0030-11
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0725
DescriptorInjection, chorionic gonadotropin, per 1,000 usp units
Billing units / pkg10 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pregnyl 78206-0150-01 Organon 1 kit $171.534 — Availability likely save 32%
Chorionic Gonadotropinthis 63323-0030-11 Fresenius 1 kit $251.584 — Availability likely —
Pregnyl 50090-7089-00 A-S 1 kit — — FDA listed —
Chorionic Gonadotropin 68071-3815-01 NuCare 1 kit — — FDA listed —
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

🏛️
1974
First FDA approval
Jan 1974
📍
2026
Currently FDA-listed
52 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
A.p.l.chorionic gonadotropin Chorionic Gonadotropin Novarelchorionic gonadotropin Pregnylchorionic gonadotropin
🔒 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 63323-0030-11, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
782
Units reimbursed last 4 qtrs
1.4K
Gross reimbursed last 4 qtrs
$386.9K
Avg / prescription
$494.82
Avg / unit
$269.74
Latest quarter Q4 2025
215Rx
Medicaid pays / ea
$269.74
gross reimbursed
vs
NADAC / ea
$251.58
acquisition cost
=
Spread
+$18.1585
+7% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
86% FFS 14% MCO
Fee-for-service · 672 Rx Managed care · 110 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 7 units · 0.1 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 782 units · 4.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 209 units · 0.5 per 100k residents CA Utah: no data reported UT Colorado: 34 units · 0.6 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 230 units · 6.4 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 5 units · 0.0 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 167 units · 0.5 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.06.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 6.4 /100k
2 New York 4.0 /100k
3 Colorado 0.6 /100k
4 Texas 0.5 /100k
5 California 0.5 /100k
6 Minnesota 0.1 /100k
7 Georgia 0.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Chorionic Gonadotropin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Chorionic Gonadotropin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$129K
Claims incl. refills
143
Beneficiaries
87
Spend / beneficiary
$1,482.39
Spend / claim
$901.87
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63323-0030-11 You're viewing this 1 KIT in 1 CARTON (63323-030-11) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL, MULTI-DOSE 2011-04-21 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

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
“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

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 FDA registers it as 63323-030-11, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63323-0030-11, written without dashes as 63323003011. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63323-0030-11, the first segment (63323) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0030) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, 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 J0725 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.

📄 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 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 174 words ▾

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 ~1 min read ▾

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 14 words ▾

CONTRAINDICATIONS: Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.

⚠️ Warnings 90 words ▾

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 18 words ▾

ADVERSE REACTIONS: Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection.

🔄 Drug / Laboratory Test Interactions 14 words ▾

Drug/Laboratory Test Interactions Chorionic gonadotropin may interfere with radioimmunoassay for gonadotropins, particularly luteinizing hormone.

🤰 Pregnancy 69 words ▾

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 19 words ▾

Pediatric Use Safety and effectiveness of chorionic gonadotropin in children below the age of four have not been established.

🧬 Clinical Pharmacology 170 words ▾

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 109 words ▾

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 184 words ▾

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63323-0024-25 · Fresenius 63323-0032-00 · Fresenius →
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.