Chorionic Gonadotropin

Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-030

Chorionic Gonadotropin is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Chorionic Gonadotropin is 63323-030. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Chorionic Gonadotropin drug includes . The currest status of Chorionic Gonadotropin drug is Active.

Drug Information:

Drug NDC:	63323-030
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Chorionic Gonadotropin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Chorionic Gonadotropin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Fresenius Kabi Usa, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Kit
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	BLA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	21 Apr, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	19 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	BLA017067
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Fresenius Kabi USA, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	896854
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
63323-030-11	1 KIT in 1 CARTON (63323-030-11) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL, MULTI-DOSE	21 Apr, 2011	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Chorionic Gonadotropin

Kit
Fresenius Kabi USA, LLC
NDC: 63323-030

Product Elements:

Chorionic gonadotropin chorionic gonadotropin chorionic gonadotropin chorionic gonadotropin choriogonadotropin alfa choriogonadotropin alfa mannitol benzyl alcohol sodium phosphate, dibasic sodium phosphate, monobasic sodium hydroxide hydrochloric acid water water hydrochloric acid water benzyl alcohol sodium hydroxide

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 âânormalââ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets. 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. selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. induction of ovulation and pregnancy in the ano Read more...

vulatory, 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.

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.

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 physicianâs 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 Read more...

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 units is recommended in the labeling for menotropins.) important: use completely within 60 days after reconstitution. refrigerate after reconstitution.

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 physicianâs 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. 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 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.

Adverse Reactions:

Adverse reactions: headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection.

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, usp is available in multiple dose vials containing 10,000 usp units with accompanying bacteriostatic water for injection for reconstitution. when reconstituted with 10 ml of the accompanying diluent each vial contains: chorionic gonadotropin 10,000 units mannitol 100 mg benzyl alcohol 0.9% 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.

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 prev Read more...

enting menstruation. hcg has no known effect on fat mobilization, appetite or sense of hunger, or body fat distribution.

How Supplied:

How supplied: chorionic gonadotropin for injection, usp, lyophilized, is supplied in two-vial packages including bacteriostatic water for injection as diluent as follows: product no. ndc no. 325011 63323-030-11 one carton containing chorionic gonadotropin for injection, usp, 10,000 usp units per vial in a 10 ml multiple dose vial with accompanying diluent. 25021 63323-025-10 chorionic gonadotropin for injection, usp, 10,000 usp units per vial in a 10 ml multiple dose vial with accompanying diluent in packages of 10. the product is assayed in accord with the usp method and potencies refer to usp units (international units) defined in terms of the usp chorionic gonadotropin reference standard. store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature].

Package Label Principal Display Panel:

Package label - principal display - chorionic gonadotropin 10 ml multiple dose vial label chorionic gonadotropin for injection, usp 10,000 usp units per vial for intramuscular use only. multiple dose vial rx only 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 package label - principal display - chorionic gonadotropin 10 ml multiple dose vial carton panel chorionic gonadotropin for injection, usp 10,000 usp units per vial for intramuscular use only. with bacteriostatic water for injection, usp as diluent rx only two-vial set 10 ml multiple dose vials vial diluent carton

Comments/ Reviews:

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