NDC 0069-1960

Cutaquig

Immunoglobulin G

Cutaquig is a Subcutaneous Solution in the Plasma Derivative category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Human Immunoglobulin G.

Product ID0069-1960_0f26c79f-3d04-7c5c-d75d-bff9405f4dff
NDC0069-1960
Product TypePlasma Derivative
Proprietary NameCutaquig
Generic NameImmunoglobulin G
Dosage FormSolution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-09-13
Marketing CategoryBLA / BLA
Application NumberBLA125668
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameHUMAN IMMUNOGLOBULIN G
Active Ingredient Strength165 mg/mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0069-1960-02

1 VIAL, GLASS in 1 CARTON (0069-1960-02) > 20 mL in 1 VIAL, GLASS (0069-1960-01)
Marketing Start Date2019-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-1960-01 [00069196001]

Cutaquig SOLUTION
Marketing CategoryBLA
Application NumberBLA125668
Product TypePLASMA DERIVATIVE
Marketing Start Date2019-09-13

NDC 0069-1960-02 [00069196002]

Cutaquig SOLUTION
Marketing CategoryBLA
Application NumberBLA125668
Product TypePLASMA DERIVATIVE
Marketing Start Date2019-09-13

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G165 mg/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Cutaquig" or generic name "Immunoglobulin G"

NDCBrand NameGeneric Name
0069-1061Cutaquigimmunoglobulin G
0069-1476Cutaquigimmunoglobulin G
0069-1509Cutaquigimmunoglobulin G
0069-1802Cutaquigimmunoglobulin G
0069-1960Cutaquigimmunoglobulin G
0069-1965Cutaquigimmunoglobulin G
68982-810Cutaquigimmunoglobulin G

Trademark Results [Cutaquig]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CUTAQUIG
CUTAQUIG
87225330 5880441 Live/Registered
Octapharma AG
2016-11-03

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