NDC 76125-918 Bivigam

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
76125-918
Proprietary Name:
Bivigam
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Kedrion Biopharma, Inc.
Labeler Code:
76125
Start Marketing Date: [9]
02-04-2013
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 76125-918-04

Package Description: 1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS (76125-918-05)

NDC Code 76125-918-09

Package Description: 1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS (76125-918-10)

Product Details

What is NDC 76125-918?

The NDC code 76125-918 is assigned by the FDA to the product Bivigam which is product labeled by Kedrion Biopharma, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 76125-918-04 1 vial, glass in 1 carton / 50 ml in 1 vial, glass (76125-918-05), 76125-918-09 1 vial, glass in 1 carton / 100 ml in 1 vial, glass (76125-918-10). 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 Bivigam?

This medication is used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections. It is also used to increase the blood count (platelets) in persons with a certain blood disorder (idiopathic thrombocytopenia purpura-ITP). Platelets are needed to stop bleeding and form blood clots. Some immune globulin products may also be used to treat a certain type of muscle weakness problem (multifocal motor neuropathy) or a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). Some products may also be used to prevent certain blood vessel disorders in people with Kawasaki syndrome.

Which are Bivigam 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)

Which are Bivigam 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:

What is the NDC to RxNorm Crosswalk for Bivigam?

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:

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Product Footnotes

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

[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".