NDC 67467-843

Octagam Immune Globulin (Human)

Immune Globulin

Octagam Immune Globulin (Human) is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.. The primary component is Human Immunoglobulin G.

Product ID67467-843_0fe33130-c3e4-4baa-db1f-4ce138e6c2e5
NDC67467-843
Product TypeHuman Prescription Drug
Proprietary NameOctagam Immune Globulin (Human)
Generic NameImmune Globulin
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2004-05-21
Marketing CategoryBLA / BLA
Application NumberBLA125062
Labeler NameOctapharma Pharmazeutika Produktionsgesellschaft m.b.H.
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 67467-843-02

50 mL in 1 BOTTLE, GLASS (67467-843-02)
Marketing Start Date2004-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67467-843-05 [67467084305]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-05-21
Inactivation Date2019-10-21

NDC 67467-843-04 [67467084304]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-05-21
Inactivation Date2019-10-21

NDC 67467-843-03 [67467084303]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-05-21
Inactivation Date2019-10-21

NDC 67467-843-01 [67467084301]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-05-21
Inactivation Date2019-10-21

NDC 67467-843-02 [67467084302]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-05-21
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G50 mg/mL

OpenFDA Data

SPL SET ID:810c8752-a7cb-0bce-777d-8539429773c2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1809643
  • 1809651
  • 1809463
  • 1809447
  • 1809456
  • 1809642
  • 1809652
  • 1809647
  • 1809649
  • 1809648
  • 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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