NDC 68209-843 Octagam Immune Globulin (human)

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:
68209-843
Proprietary Name:
Octagam Immune Globulin (human)
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Octapharma Ab
Labeler Code:
68209
Start Marketing Date: [9]
04-14-2006
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 68209-843-01

Package Description: 20 mL in 1 BOTTLE, GLASS

NDC Code 68209-843-02

Package Description: 50 mL in 1 BOTTLE, GLASS

NDC Code 68209-843-03

Package Description: 100 mL in 1 BOTTLE, GLASS

NDC Code 68209-843-04

Package Description: 200 mL in 1 BOTTLE, GLASS

Product Details

What is NDC 68209-843?

The NDC code 68209-843 is assigned by the FDA to the product Octagam Immune Globulin (human) which is product labeled by Octapharma Ab. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 68209-843-01 20 ml in 1 bottle, glass , 68209-843-02 50 ml in 1 bottle, glass , 68209-843-03 100 ml in 1 bottle, glass , 68209-843-04 200 ml in 1 bottle, glass . 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 Octagam Immune Globulin (human)?

Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin. Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/ml in a 5% solution). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity (See Description [11]). Octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid.

Which are Octagam Immune Globulin (human) 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 Octagam Immune Globulin (human)?

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".