FDA.reportPublic FDA data

CUVITRU

Product NDC
0944-2850
11-digit product format
009442850
Labeler code
0944
Product ID
0944-2850_195585b0-5cd1-4638-9765-224db70d6e44
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin Subcutaneous (Human)
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA125596
Marketing category
BLA
Marketing start
2016-10-18
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
200 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
CUVITRU
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G200 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2850-01CUVITRU1 in 1 CARTONINJECTION, SOLUTION119
0944-2850-02CUVITRU5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION519
0944-2850-03CUVITRU1 in 1 CARTONINJECTION, SOLUTION119
0944-2850-04CUVITRU10 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1019
0944-2850-05CUVITRU1 in 1 CARTONINJECTION, SOLUTION119
0944-2850-06CUVITRU20 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION2019
0944-2850-07CUVITRU1 in 1 CARTONINJECTION, SOLUTION119
0944-2850-08CUVITRU40 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION4019
0944-2850-09CUVITRU1 in 1 CARTONINJECTION, SOLUTION119
0944-2850-10CUVITRU50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-2850-01ML - Milliliter0944-2850c58db1fc-0e11-4002-8d41-96f00f55f7fc12016-11-08
0944-2850-02ML - Milliliter0944-285020d36891-5cb5-4e05-9b58-345ed79c5bd312016-11-08
0944-2850-03ML - Milliliter0944-2850f5021b91-d03e-4c36-ada4-a520ed2a68ae12016-11-08
0944-2850-04ML - Milliliter0944-28509705ff29-87d6-4741-b16d-6528bea1b6cc12016-11-08
0944-2850-05ML - Milliliter0944-2850da8fb69e-89f3-4e44-8fe0-6de09409984112016-11-08
0944-2850-06ML - Milliliter0944-2850c3580c6f-014a-4f58-ae2c-57452369b98a12016-11-08
0944-2850-07ML - Milliliter0944-28507f9f1d01-9cf7-4cee-9feb-bd1bdf9816af12016-11-08
0944-2850-08ML - Milliliter0944-285078519672-4a4a-405b-a25a-d043b5279f6912016-11-08
0944-2850-09ML - Milliliter0944-2850fd4d2d8d-34db-4133-b0ce-d99666dd73af12019-08-06
0944-2850-10ML - Milliliter0944-2850333cde41-e012-4ff1-b52c-780ed0a024e312019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2850CUVITRU (IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN)) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]18Current NDC, Legacy NDC, 10 package rows20250311_9aad7ec9-6097-4805-8f1b-898bec35f218.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1813417CUVITRU 20 % in 10 mL InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
1813420CUVITRU 20 % in 20 mL InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
1813424CUVITRU 20 % in 40 mL InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
1813415CUVITRU 20 % in 5 mL InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
2117971CUVITRU 20 % in 50 ML InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
1809068immunoglobulin G, human 20 % in 10 ML InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
1809066immunoglobulin G, human 20 % in 20 ML InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
1813423immunoglobulin G, human 20 % in 40 mL InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
1809076immunoglobulin G, human 20 % in 5 ML InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
1809061immunoglobulin G, human 20 % in 50 ML InjectionPSN9aad7ec9-6097-4805-8f1b-898bec35f21819
181341710 ML immunoglobulin G, human 200 MG/ML Injection [Cuvitru]SBD9aad7ec9-6097-4805-8f1b-898bec35f21819
181342020 ML immunoglobulin G, human 200 MG/ML Injection [Cuvitru]SBD9aad7ec9-6097-4805-8f1b-898bec35f21819
181342440 ML immunoglobulin G, human 200 MG/ML Injection [Cuvitru]SBD9aad7ec9-6097-4805-8f1b-898bec35f21819
18134155 ML immunoglobulin G, human 200 MG/ML Injection [Cuvitru]SBD9aad7ec9-6097-4805-8f1b-898bec35f21819
211797150 ML immunoglobulin G, human 200 MG/ML Injection [Cuvitru]SBD9aad7ec9-6097-4805-8f1b-898bec35f21819
180906810 ML immunoglobulin G, human 200 MG/ML InjectionSCD9aad7ec9-6097-4805-8f1b-898bec35f21819
180906620 ML immunoglobulin G, human 200 MG/ML InjectionSCD9aad7ec9-6097-4805-8f1b-898bec35f21819
181342340 ML immunoglobulin G, human 200 MG/ML InjectionSCD9aad7ec9-6097-4805-8f1b-898bec35f21819
18090765 ML immunoglobulin G, human 200 MG/ML InjectionSCD9aad7ec9-6097-4805-8f1b-898bec35f21819
180906150 ML immunoglobulin G, human 200 MG/ML InjectionSCD9aad7ec9-6097-4805-8f1b-898bec35f21819
211797150 ML Cuvitru 200 MG/ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813415CUVITRU 1 GM per 5 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813417CUVITRU 2 GM per 10 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813417CUVITRU 20 % per 10 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813420CUVITRU 20 % per 20 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813424CUVITRU 20 % per 40 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813415CUVITRU 20 % per 5 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
2117971CUVITRU 20 % per 50 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813420CUVITRU 4 GM per 20 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813424CUVITRU 8 GM per 40 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1809076immunoglobulin G, human 1 GM per 5 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1809061immunoglobulin G, human 10 GM per 50 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1809068immunoglobulin G, human 2 GM per 10 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1809068immunoglobulin G, human 20 % per 10 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1809066immunoglobulin G, human 20 % per 20 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813423immunoglobulin G, human 20 % per 40 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1809076immunoglobulin G, human 20 % per 5 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1809061immunoglobulin G, human 20 % per 50 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1809066immunoglobulin G, human 4 GM per 20 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819
1813423immunoglobulin G, human 8 GM per 40 ML InjectionSY9aad7ec9-6097-4805-8f1b-898bec35f21819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0944-2850-01009442850011 VIAL, SINGLE-USE in 1 CARTON (0944-2850-01) / 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02) 2016-10-180000-00-00NoNoCurrent
0944-2850-02009442850025 mL in 1 VIAL, SINGLE-USE5 mlHistorical
0944-2850-03009442850031 VIAL, SINGLE-USE in 1 CARTON (0944-2850-03) / 10 mL in 1 VIAL, SINGLE-USE (0944-2850-04) 2016-10-180000-00-00NoNoCurrent
0944-2850-040094428500410 mL in 1 VIAL, SINGLE-USE10 mlHistorical
0944-2850-05009442850051 VIAL, SINGLE-USE in 1 CARTON (0944-2850-05) / 20 mL in 1 VIAL, SINGLE-USE (0944-2850-06) 2016-10-180000-00-00NoNoCurrent
0944-2850-060094428500620 mL in 1 VIAL, SINGLE-USE20 mlHistorical
0944-2850-07009442850071 VIAL, SINGLE-USE in 1 CARTON (0944-2850-07) / 40 mL in 1 VIAL, SINGLE-USE (0944-2850-08) 2016-10-180000-00-00NoNoCurrent
0944-2850-080094428500840 mL in 1 VIAL, SINGLE-USE40 mlHistorical
0944-2850-09009442850091 BOTTLE, GLASS in 1 CARTON (0944-2850-09) / 50 mL in 1 BOTTLE, GLASS (0944-2850-10) 2016-10-180000-00-00NoNoCurrent
0944-2850-100094428501050 mL in 1 BOTTLE, GLASS50 mlHistorical