FDA.reportPublic FDA data

Cutaquig

Product NDC
68982-810
11-digit product format
689820810
Labeler code
68982
Product ID
68982-810_92279fbb-b633-80a9-0e99-5883db7ca60b
Type
PLASMA DERIVATIVE
Nonproprietary name
immunoglobulin G
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Octapharma USA Inc
Application
BLA125668
Marketing category
BLA
Marketing start
2019-05-03
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
68982-810-01Cutaquig1 in 1 CARTONSOLUTION113
68982-810-02Cutaquig1 in 1 CARTONSOLUTION113
68982-810-03Cutaquig1 in 1 CARTONSOLUTION113
68982-810-04Cutaquig1 in 1 CARTONSOLUTION113
68982-810-05Cutaquig1 in 1 CARTONSOLUTION113
68982-810-06Cutaquig1 in 1 CARTONSOLUTION113
68982-810-81Cutaquig6 mL in 1 VIAL, GLASSSOLUTION613
68982-810-82Cutaquig10 mL in 1 VIAL, GLASSSOLUTION1013
68982-810-83Cutaquig12 mL in 1 VIAL, GLASSSOLUTION1213
68982-810-84Cutaquig20 mL in 1 VIAL, GLASSSOLUTION2013
68982-810-85Cutaquig24 mL in 1 VIAL, GLASSSOLUTION2413
68982-810-86Cutaquig48 mL in 1 VIAL, GLASSSOLUTION4813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-810-01ML - Milliliter68982-810b07cbb1f-1c2e-4b54-ab9a-39d3125c830512019-06-19
68982-810-02ML - Milliliter68982-8108afc7c77-aba3-4f8a-bf1a-8f71cdb15e2812019-06-19
68982-810-03ML - Milliliter68982-810af47c63b-ba22-470d-afd5-de67a491776612019-06-19
68982-810-04ML - Milliliter68982-8108632eb4d-611f-4777-a6e0-7d0a0e05492412019-06-19
68982-810-05ML - Milliliter68982-810f7e1c2cf-3109-4a0d-8560-dbc96bff706012019-06-19
68982-810-06ML - Milliliter68982-810d257e38a-6977-4a56-926b-c6f93417b4a612019-06-19
68982-810-81ML - Milliliter68982-81099ad63d0-d96e-46d8-807f-ce934a40299312019-06-19
68982-810-82ML - Milliliter68982-81049815561-3ca0-46ba-9246-3f43fe6c662b12019-06-19
68982-810-83ML - Milliliter68982-8100399472a-c45f-4388-9752-86968d7e0b8b12019-06-19
68982-810-84ML - Milliliter68982-8109732c748-33c5-4f72-9c39-87a705feae4812019-06-19
68982-810-85ML - Milliliter68982-810268b416a-8163-4f01-8a85-2e5a586cfa4612019-06-19
68982-810-86ML - Milliliter68982-81071374fc9-637f-4a5a-8209-f500601b0d9712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-810CUTAQUIG (IMMUNOGLOBULIN G) SOLUTION [OCTAPHARMA USA INC]13Current NDC, Legacy NDC, 12 package rows20220429_f3de095f-791a-85dc-7a14-ec7790cb13aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2167152cutaquig 16.5 % (1 GM in 6 ML) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167159cutaquig 16.5 % (1.65 GM in 10 ML) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167157cutaquig 16.5 % (2 GM in 12 ML) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167161cutaquig 16.5 % (3.3 GM in 20 ML) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167163cutaquig 16.5 % (4 GM in 24 ML) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167165cutaquig 16.5 % (8 GM in 48 ML) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167147immune globulin subcutaneous (human) - hipp 16.5 % (1 GM in 6 mL) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167158immune globulin subcutaneous (human) - hipp 16.5 % (1.65 GM in 10 mL) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167156immune globulin subcutaneous (human) - hipp 16.5 % (2 GM in 12 mL) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167160immune globulin subcutaneous (human) - hipp 16.5 % (3.3 GM in 20 mL) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167162immune globulin subcutaneous (human) - hipp 16.5 % (4 GM in 24 mL) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167164immune globulin subcutaneous (human) - hipp 16.5 % (8 GM in 48 mL) InjectionPSNf3de095f-791a-85dc-7a14-ec7790cb13aa13
216715910 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216715712 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716120 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716324 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716548 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf3de095f-791a-85dc-7a14-ec7790cb13aa13
21671526 ML immune globulin subcutaneous (human) - hipp 165 MG/ML Injection [Cutaquig]SBDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216715810 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216715612 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716020 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716224 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716448 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf3de095f-791a-85dc-7a14-ec7790cb13aa13
21671476 ML immune globulin subcutaneous (human) - hipp 165 MG/ML InjectionSCDf3de095f-791a-85dc-7a14-ec7790cb13aa13
216715910 ML Cutaquig 165 MG/ML InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216715810 ML immune globulin subcutaneous (human) - hipp 16.5 % (1.65 GM per 10 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216715712 ML Cutaquig 165 MG/ML InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216715612 ML immune globulin subcutaneous (human) - hipp 16.5 % (2 GM per 12 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716120 ML Cutaquig 165 MG/ML InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716020 ML immune globulin subcutaneous (human) - hipp 16.5 % (3.3 GM per 20 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716324 ML Cutaquig 165 MG/ML InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716224 ML immune globulin subcutaneous (human) - hipp 16.5 % (4 GM per 24 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716548 ML Cutaquig 165 MG/ML InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
216716448 ML immune globulin subcutaneous (human) - hipp 16.5 % (8 GM per 48 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
21671526 ML Cutaquig 165 MG/ML InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
21671476 ML immune globulin subcutaneous (human) - hipp 16.5 % (1 GM per 6 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167152cutaquig 16.5 % (1 GM per 6 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167159cutaquig 16.5 % (1.65 GM per 10 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167157cutaquig 16.5 % (2 GM per 12 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167161cutaquig 16.5 % (3.3 GM per 20 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167163cutaquig 16.5 % (4 GM per 24 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13
2167165cutaquig 16.5 % (8 GM per 48 ML) InjectionSYf3de095f-791a-85dc-7a14-ec7790cb13aa13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68982-810-01689820810011 VIAL, GLASS in 1 CARTON (68982-810-01) / 6 mL in 1 VIAL, GLASS (68982-810-81) 2019-05-030000-00-00NoNoCurrent
68982-810-02689820810021 VIAL, GLASS in 1 CARTON (68982-810-02) / 10 mL in 1 VIAL, GLASS (68982-810-82) 2019-05-030000-00-00NoNoCurrent
68982-810-03689820810031 VIAL, GLASS in 1 CARTON (68982-810-03) / 12 mL in 1 VIAL, GLASS (68982-810-83) 2019-05-030000-00-00NoNoCurrent
68982-810-04689820810041 VIAL, GLASS in 1 CARTON (68982-810-04) / 20 mL in 1 VIAL, GLASS (68982-810-84) 2019-05-030000-00-00NoNoCurrent
68982-810-05689820810051 VIAL, GLASS in 1 CARTON (68982-810-05) / 24 mL in 1 VIAL, GLASS (68982-810-85) 2019-05-030000-00-00NoNoCurrent
68982-810-06689820810061 VIAL, GLASS in 1 CARTON (68982-810-06) / 48 mL in 1 VIAL, GLASS (68982-810-86) 2019-05-030000-00-00NoNoCurrent
68982-810-81689820810816 mL in 1 VIAL, GLASS6 mlHistorical
68982-810-826898208108210 mL in 1 VIAL, GLASS10 mlHistorical
68982-810-836898208108312 mL in 1 VIAL, GLASS12 mlHistorical
68982-810-846898208108420 mL in 1 VIAL, GLASS20 mlHistorical
68982-810-856898208108524 mL in 1 VIAL, GLASS24 mlHistorical
68982-810-866898208108648 mL in 1 VIAL, GLASS48 mlHistorical