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NDC 83703-041 Hyqvia

Immune Globulin Infusion 10% (human) With Recombinant Human Hyaluronidase Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83703-041?
  4. Hyqvia Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
83703-041
Proprietary Name:
Hyqvia
Non-Proprietary Name: [1]
Immune Globulin Infusion 10% (human) With Recombinant Human Hyaluronidase
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Bamboo Us Bidco Llc
Labeler Code:
83703
Product Label ID:
1a52ca88-a13c-7c67-e063-6394a90a1f67
FDA Application Number: [6]
BLA125402
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
09-12-2014
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
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Product Details

What is NDC 83703-041?

The NDC code 83703-041 is assigned by the FDA to the product Hyqvia which is a plasma derivative product labeled by Bamboo Us Bidco Llc. The generic name of Hyqvia is immune globulin infusion 10% (human) with recombinant human hyaluronidase. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 83703-041-02 1 kit in 1 carton * 200 ml in 1 vial, glass (0944-2718-20) * 10 ml in 1 vial, glass (0944-2723-03). 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 Hyqvia?

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.

Which are Hyqvia 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)
  • HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8)
  • HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (Active Moiety)

Which are Hyqvia Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

* 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.

[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.

[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".