FDA.reportPublic FDA data

Cutaquig

Product NDC
68982-810
Requested package NDC
68982-810-02
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
66Y330CJHSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2167147Internal RxNorm lookup
2167152Internal RxNorm lookup
2167156Internal RxNorm lookup
2167157Internal RxNorm lookup
2167158Internal RxNorm lookup
2167159Internal RxNorm lookup
2167160Internal RxNorm lookup
2167161Internal RxNorm lookup
2167162Internal RxNorm lookup
2167163Internal RxNorm lookup
2167164Internal RxNorm lookup
2167165Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3de095f-791a-85dc-7a14-ec7790cb13aaAvailable on FDA.report

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125668CutaquigImmune Globulin Subcutaneous (Human)-hipp351(a)Rx2026-10-01

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
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