NDC 76179-010-02 HUMAN PRESCRIPTION DRUG

Drug Status:  Active

Proprietary Name: Qivigy Kthm

Drug Overview

The NDC Code 76179-010-02 is assigned to “Qivigy Kthm” (also known as: “Human Immunoglobulin G”), a human prescription drug labeled by “Kedrion S.p.A.”. The product's dosage form is injection, solution, and is administered via intravenous form.

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Drug Information
NDC Package Code	76179-010-02
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	76179-010
	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.
11 Digit NDC Code	76179-0010-02
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Qivigy
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Human Immunoglobulin G
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	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. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Proprietary Name Suffix	Kthm
	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
Labeler Name	Kedrion S.p.A.
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Active
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Description	QIVIGY (immune globulin intravenous, human-kthm) is a ready-to-use, sterile, non-pyrogenic liquid solution of human immune globulin (IgG) for intravenous administration. QIVIGY is clear or slightly opalescent, colorless or pale yellow. QIVIGY consists of immune globulin of which IgG represents at least 96% of the total protein. It consists of 9 - 11% protein in 0.20 - 0.28 M glycine. In the solution, the IgG proteins are present by more than 97% (at lot release) and 93% (by expiration date) in monomeric and dimeric forms. Minimum value for osmolality is: 240 mOsmol/Kg. pH of the solution is in the range of 4.0 - 4.5. It contains trace levels of IgA (not more than 50 mg/L). The main component of QIVIGY is IgG (≥ 96%) with a sub-class distribution compatible with native human plasma. QIVIGY contains no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative. To specifically reduce the anti-A and anti-B titers in the drug product (isoagglutinins A and B), donor plasma is screened for isoagglutinin titer using a validated assay, and plasma units with high agglutination scores are excluded from further processing. All donors of plasma are carefully screened by history and laboratory testing to reduce the risk of transmitting blood-borne pathogens from infected donors. All plasma units used in the manufacture of QIVIGY are tested and approved for manufacture using FDA-licensed serological assays for Hepatitis B surface antigen (HBsAg), Human immunodeficiency virus 1/2 antibodies (anti-HIV-1/2), and Hepatitis C antibodies (anti-HCV). In addition, donations are screened for Hepatitis C virus (HCV), Human immunodeficiency virus 1 (HIV-1), Hepatitis B virus (HBV), Hepatitis A virus (HAV) and Parvovirus B19 (B19V) by NAT. Further testing is performed on the manufacturing pools for HBsAg and antibodies to HIV-1/2; plasma pools are also tested for HCV, HIV-1, HBV, HAV and B19V by NAT with the limit for B19V set to not exceed 104 IU B19V DNA per mL plasma. QIVIGY is made from large pools of human plasma by a combination of cold alcohol fractionation, caprylate precipitation and filtration, anion-exchange chromatography, nanofiltration and ultrafiltration/diafiltration (UF/DF). QIVIGY is incubated in the final container at the low pH of 4.0 – 4.5. The product is intended for intravenous administration. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by spiking studies at laboratory scale with a validated model of the manufacturing processes, using the following enveloped and non-enveloped viruses: HIV-1 as the relevant virus for HIV-1 and HIV–2; Bovine Viral Diarrhea virus (BVDV) as a model for HCV; Pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., Herpes viruses and HBV); HAV as relevant non-enveloped virus, Encephalomyocarditis virus (EMCV) as a model for HAV, and Porcine Parvovirus (PPV) as a model for human parvovirus B19. The viral clearance capacity of QIVIGY manufacturing process has been evaluated by summing logarithmic reduction factors from single steps with significant reduction factors more than 1 log, obtaining overall log reduction factors (LRFs) reported in Table 3. The manufacturing process for QIVIGY includes four steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: sodium caprylate incubation to inactivate enveloped viruses and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, caprylate precipitation and filtration step and low pH treatment step contributes to the virus reduction capacity. Overall virus reduction was calculated only from steps that were orthogonal in mechanisms of removal/inactivation. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Concerning vCJD risk, donor exclusion criteria are in accordance with the relevant FDA Guidance for Industry (Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Components, current edition).
	General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Indication And Usage	QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	INJECTION, SOLUTION
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	INTRAVENOUS
	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.
Pharmaceutical Classes	ANTIGEN NEUTRALIZATION [MOA], HUMAN IMMUNOGLOBULIN G [EPC], IMMUNOGLOBULINS [CS], PASSIVELY ACQUIRED IMMUNITY [PE]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	HUMAN IMMUNOGLOBULIN G - 5 mg/50mL
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	76179-010-02
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	1 VIAL, GLASS IN 1 CARTON (76179-010-02) / 50 ML IN 1 VIAL, GLASS (76179-010-01)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	20250926
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package 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. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	76179-010
	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.
Application Number	BLA125822
	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.
Marketing Category Name	BLA
	Product types are broken down into several potential Marketing Categories, such as NDA/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.
Listing Record Certified Through	20261231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20250926
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	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.
Product NDC Exclude Flag	N
	This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Tracking Information
Last Update Date	2025-12-03
	The date that a record was last updated or changed.