44206-310 NDC - CYTOGAM ()

Drug Information

  • Product NDC: 44206-310
  • Proprietary Name: Cytogam
  • Non Proprietary Name:
  • Active Ingredient(s): 12.5 g/250mL ALBUMIN HUMAN
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Human Serum Albumin [EPC]; Increased Intravascular Volume [PE]; Increased Oncotic Pressure [PE]; Osmotic Activity [MoA]; Serum Albumin [Chemical/Ingredient]

Labeler Information

Field Name Field Value
Labeler Name: CSL Behring AG
Product Type:
FDA Application Number: BLA103189
Marketing Category: BLA
Start Marketing Date:1/6/2009
End Marketing Date:2/16/2011

Package Information

No. Package Code Package Description Billing Unit
144206-310-111 VIAL, GLASS in 1 CARTON (44206-310-11) / 50 mL in 1 VIAL, GLASS
244206-310-251 VIAL, GLASS in 1 CARTON (44206-310-25) / 250 mL in 1 VIAL, GLASS (44206-310-90)ML
344206-310-501 VIAL, GLASS in 1 CARTON (44206-310-50) / 500 mL in 1 VIAL, GLASS (44206-310-91)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC44206-310The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMECytogamThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/6/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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.
APPLICATION NUMBERBLA103189This 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.
LABELER NAMECSL Behring AGName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC44206-310The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEALBURXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/6/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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.
APPLICATION NUMBERBLA102366This 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.
LABELER NAMECSL Behring AGName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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