NDC 68209-843

Octagam Immune Globulin (Human)

Immune Globulin

Octagam Immune Globulin (Human) is a Intravenous Solution in the Plasma Derivative category. It is labeled and distributed by Octapharma Ab. The primary component is Human Immunoglobulin G.

Product ID68209-843_0e0a702d-888c-e29e-e8bf-9910b8719d1c
NDC68209-843
Product TypePlasma Derivative
Proprietary NameOctagam Immune Globulin (Human)
Generic NameImmune Globulin
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2006-04-14
Marketing CategoryBLA / BLA
Application NumberBLA125062
Labeler NameOctapharma AB
Substance NameHUMAN IMMUNOGLOBULIN G
Active Ingredient Strength50 mg/mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68209-843-02

50 mL in 1 BOTTLE, GLASS (68209-843-02)
Marketing Start Date2006-04-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68209-843-01 [68209084301]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2006-04-14
Inactivation Date2019-11-27

NDC 68209-843-04 [68209084304]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2006-04-14
Inactivation Date2019-11-27

NDC 68209-843-02 [68209084302]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2006-04-14
Inactivation Date2019-11-27

NDC 68209-843-03 [68209084303]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2006-04-14
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G50 mg/mL

Pharmacological Class

  • Human Immunoglobulin G [EPC]
  • Passively Acquired Immunity [PE]
  • Antigen Neutralization [MoA]
  • Immunoglobulins [CS]

NDC Crossover Matching brand name "Octagam Immune Globulin (Human)" or generic name "Immune Globulin"

NDCBrand NameGeneric Name
67467-843Octagam Immune Globulin (Human)Immune Globulin
68209-843Octagam Immune Globulin (Human)Immune Globulin
68982-840Octagam Immune Globulin (Human)Immune Globulin
68982-850Octagam Immune Globulin (Human)Immune Globulin

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