NDC 0069-1802 Cutaquig

Immunoglobulin G Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0069-1802
Proprietary Name:
Cutaquig
Non-Proprietary Name: [1]
Immunoglobulin G
Substance Name: [2]
Human Immunoglobulin G
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Pfizer Laboratories Div Pfizer Inc
    Labeler Code:
    0069
    FDA Application Number: [6]
    BLA125668
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    09-13-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0069-1802-02

    Package Description: 1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS (0069-1802-01)

    Product Details

    What is NDC 0069-1802?

    The NDC code 0069-1802 is assigned by the FDA to the product Cutaquig which is a plasma derivative product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Cutaquig is immunoglobulin g. The product's dosage form is solution and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 0069-1802-02 1 vial, glass in 1 carton / 10 ml in 1 vial, glass (0069-1802-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Cutaquig?

    CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

    What are Cutaquig Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Cutaquig UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS)
    • HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (Active Moiety)

    What is the NDC to RxNorm Crosswalk for Cutaquig?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 2167147 - immune globulin subcutaneous (human) - hipp 16.5 % (1 GM in 6 mL) Injection
    • RxCUI: 2167147 - 6 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection
    • RxCUI: 2167147 - 6 ML immune globulin subcutaneous (human) - hipp 16.5 % (1 GM per 6 ML) Injection
    • RxCUI: 2167152 - cutaquig 16.5 % (1 GM in 6 ML) Injection
    • RxCUI: 2167152 - 6 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]

    Which are the Pharmacologic Classes for Cutaquig?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - 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.

    [8] What is the Marketing Category? - 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".