NDC 68982-820 Panzyga

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:
68982-820
Proprietary Name:
Panzyga
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Octapharma Usa Inc
Labeler Code:
68982
Start Marketing Date: [9]
11-12-2018
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Packages

NDC Code 68982-820-01

Package Description: 1 BOTTLE, GLASS in 1 CARTON / 10 mL in 1 BOTTLE, GLASS (68982-820-81)

NDC Code 68982-820-02

Package Description: 1 BOTTLE, GLASS in 1 CARTON / 25 mL in 1 BOTTLE, GLASS (68982-820-82)

NDC Code 68982-820-03

Package Description: 1 BOTTLE, GLASS in 1 CARTON / 50 mL in 1 BOTTLE, GLASS (68982-820-83)

NDC Code 68982-820-04

Package Description: 1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS (68982-820-84)

NDC Code 68982-820-05

Package Description: 1 BOTTLE, GLASS in 1 CARTON / 200 mL in 1 BOTTLE, GLASS (68982-820-85)

NDC Code 68982-820-06

Package Description: 1 BOTTLE, GLASS in 1 CARTON / 300 mL in 1 BOTTLE, GLASS (68982-820-86)

Product Details

What is NDC 68982-820?

The NDC code 68982-820 is assigned by the FDA to the product Panzyga which is product labeled by Octapharma Usa Inc. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 68982-820-01 1 bottle, glass in 1 carton / 10 ml in 1 bottle, glass (68982-820-81), 68982-820-02 1 bottle, glass in 1 carton / 25 ml in 1 bottle, glass (68982-820-82), 68982-820-03 1 bottle, glass in 1 carton / 50 ml in 1 bottle, glass (68982-820-83), 68982-820-04 1 bottle, glass in 1 carton / 100 ml in 1 bottle, glass (68982-820-84), 68982-820-05 1 bottle, glass in 1 carton / 200 ml in 1 bottle, glass (68982-820-85), 68982-820-06 1 bottle, glass in 1 carton / 300 ml in 1 bottle, glass (68982-820-86). 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 Panzyga?

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 Panzyga 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 Panzyga?

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: 2102435 - immune globulin intravenous (human) - ifas 10 % in 10 ML Injection
  • RxCUI: 2102435 - 10 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection
  • RxCUI: 2102435 - immune globulin intravenous (human) - ifas 10 % per 10 ML Injection
  • RxCUI: 2102440 - panzyga 10 % in 10 ML Injection
  • RxCUI: 2102440 - 10 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]

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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".