NDC 0944-2514-02 Hyqvia
Immune Globulin 10 Percent (human) With Recombinant Human Hyaluronidase Kit

Package Information

The NDC Code 0944-2514-02 is assigned to a package of 1 kit in 1 carton * 300 ml in 1 vial, glass (0944-2719-30) * 15 ml in 1 vial, glass (0944-2724-03) of Hyqvia, a plasma derivative labeled by Baxalta Us Inc.. The product's dosage form is kit and is administered via form.

Field Name Field Value
NDC Code 0944-2514-02
Package Description 1 KIT in 1 CARTON * 300 mL in 1 VIAL, GLASS (0944-2719-30) * 15 mL in 1 VIAL, GLASS (0944-2724-03)
Product Code 0944-2514
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Hyqvia
Non-Proprietary Name 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.
Immune Globulin 10 Percent (human) With Recombinant Human Hyaluronidase
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
This kit contains two medications: immune globulin and hyaluronidase. Immune globulin is used to boost the body's natural defense system against infection in persons with a weakened immune system (primary immune deficiency). Immune globulin contains natural substances called antibodies (a type called IgG) that come from healthy human blood (plasma). These antibodies help protect your body against infections and help you to fight an infection if you get sick. Hyaluronidase is used to help the body absorb the immune globulin.
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
00944251402
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk
  • RxCUI: 1549687 - {1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack
  • RxCUI: 1549687 - immunoglobulin G, human 30 GM / hyaluronidase, human recombinant 2400 UNT Kit
  • RxCUI: 1549688 - {1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 30 G / 300 ML Kit]
  • RxCUI: 1549688 - HYQVIA 30 GM / 300 ML Kit
  • RxCUI: 1549688 - Hyqvia 2400 UNT per 15 ML / 30 G per 300 ML (10 % ) Kit
  • Product Type 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.
    Plasma Derivative
    Labeler Name Baxalta Us Inc.
    Dosage Form Kit - A packaged collection of related material.
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category 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.
    BLA - A product marketed under an approved Biologic License Application.
    FDA Application Number 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.
    BLA125402
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    09-12-2014
    Listing Expiration Date 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.
    12-31-2022
    Exclude Flag 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".
    N
    NDC Code Structure

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0944-2514-02 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00944251402J1575Hyqvia 100mg immuneglobulin100 MG3001300300

    * Please review the disclaimer below.