NDC 68982-840

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 Usa Inc. The primary component is Human Immunoglobulin G.

Product ID68982-840_1ceaed06-d43c-a23d-a4e0-dce0de4ad7f0
NDC68982-840
Product TypePlasma Derivative
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 USA Inc
Substance NameHUMAN IMMUNOGLOBULIN G
Active Ingredient Strength50 mg/mL
Pharm ClassesAntigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68982-840-01

20 mL in 1 BOTTLE, GLASS (68982-840-01)
Marketing Start Date2004-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68982-840-03 [68982084003]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2004-05-21

NDC 68982-840-02 [68982084002]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2004-05-21

NDC 68982-840-01 [68982084001]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2004-05-21

NDC 68982-840-05 [68982084005]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2004-05-21

NDC 68982-840-04 [68982084004]

Octagam Immune Globulin (Human) SOLUTION
Marketing CategoryBLA
Application NumberBLA125062
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2004-05-21

Drug Details

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.