FDA.reportPublic FDA data

Cutaquig

Product NDC
0069-1960
11-digit product format
000691960
Labeler code
0069
Product ID
0069-1960_65f206aa-2273-42cd-affc-abbd9f43500c
Type
PLASMA DERIVATIVE
Nonproprietary name
immunoglobulin G
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA125668
Marketing category
BLA
Marketing start
2019-09-13
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
165 mg/mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cutaquig
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G165 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1960-01Cutaquig20 mL in 1 VIAL, GLASSSOLUTION2015
0069-1960-02Cutaquig1 in 1 CARTONSOLUTION115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1960CUTAQUIG (IMMUNOGLOBULIN G) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]14Current NDC, Legacy NDC, 2 package rows20250328_f199187a-de4e-2047-0aee-b6d93390b3d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2167152cutaquig 16.5 % (1 GM in 6 ML) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167159cutaquig 16.5 % (1.65 GM in 10 ML) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167157cutaquig 16.5 % (2 GM in 12 ML) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167161cutaquig 16.5 % (3.3 GM in 20 ML) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167163cutaquig 16.5 % (4 GM in 24 ML) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167165cutaquig 16.5 % (8 GM in 48 ML) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167147immune globulin subcutaneous (human) - hipp 16.5 % (1 GM in 6 mL) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167158immune globulin subcutaneous (human) - hipp 16.5 % (1.65 GM in 10 mL) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167156immune globulin subcutaneous (human) - hipp 16.5 % (2 GM in 12 mL) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167160immune globulin subcutaneous (human) - hipp 16.5 % (3.3 GM in 20 mL) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167162immune globulin subcutaneous (human) - hipp 16.5 % (4 GM in 24 mL) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
2167164immune globulin subcutaneous (human) - hipp 16.5 % (8 GM in 48 mL) InjectionPSNf199187a-de4e-2047-0aee-b6d93390b3d215
216715910 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf199187a-de4e-2047-0aee-b6d93390b3d215
216715712 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf199187a-de4e-2047-0aee-b6d93390b3d215
216716120 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf199187a-de4e-2047-0aee-b6d93390b3d215
216716324 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf199187a-de4e-2047-0aee-b6d93390b3d215
216716548 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf199187a-de4e-2047-0aee-b6d93390b3d215
21671526 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf199187a-de4e-2047-0aee-b6d93390b3d215
216715810 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf199187a-de4e-2047-0aee-b6d93390b3d215
216715612 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf199187a-de4e-2047-0aee-b6d93390b3d215
216716020 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf199187a-de4e-2047-0aee-b6d93390b3d215
216716224 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf199187a-de4e-2047-0aee-b6d93390b3d215
216716448 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf199187a-de4e-2047-0aee-b6d93390b3d215
21671476 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf199187a-de4e-2047-0aee-b6d93390b3d215
216715910 ML Cutaquig 165 MG/ML InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216715810 ML immune globulin subcutaneous (human) - hipp 16.5 % (1.65 GM per 10 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216715712 ML Cutaquig 165 MG/ML InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216715612 ML immune globulin subcutaneous (human) - hipp 16.5 % (2 GM per 12 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216716120 ML Cutaquig 165 MG/ML InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216716020 ML immune globulin subcutaneous (human) - hipp 16.5 % (3.3 GM per 20 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216716324 ML Cutaquig 165 MG/ML InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216716224 ML immune globulin subcutaneous (human) - hipp 16.5 % (4 GM per 24 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216716548 ML Cutaquig 165 MG/ML InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
216716448 ML immune globulin subcutaneous (human) - hipp 16.5 % (8 GM per 48 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
21671526 ML Cutaquig 165 MG/ML InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
21671476 ML immune globulin subcutaneous (human) - hipp 16.5 % (1 GM per 6 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
2167152cutaquig 16.5 % (1 GM per 6 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
2167159cutaquig 16.5 % (1.65 GM per 10 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
2167157cutaquig 16.5 % (2 GM per 12 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
2167161cutaquig 16.5 % (3.3 GM per 20 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
2167163cutaquig 16.5 % (4 GM per 24 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215
2167165cutaquig 16.5 % (8 GM per 48 ML) InjectionSYf199187a-de4e-2047-0aee-b6d93390b3d215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-1960-010006919600120 mL in 1 VIAL, GLASS20 mlHistorical
0069-1960-02000691960021 VIAL, GLASS in 1 CARTON (0069-1960-02) / 20 mL in 1 VIAL, GLASS (0069-1960-01) 2019-09-130000-00-00NoNoCurrent