FDA.reportPublic FDA data

Hizentra

Product NDC
44206-452
11-digit product format
442060452
Labeler code
44206
Product ID
44206-452_411c01a7-0ae7-45d2-8b4c-cbe99a2ba264
Type
PLASMA DERIVATIVE
Nonproprietary name
HUMAN IMMUNOGLOBULIN G
Dosage form
LIQUID
Route
SUBCUTANEOUS
Labeler
CSL Behring AG
Application
BLA125350
Marketing category
BLA
Marketing start
2011-10-03
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
.2 g/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
Hizentra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G.2 g/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
44206-452-02Hizentra1 in 1 CARTONLIQUID126
44206-452-91Hizentra10 mL in 1 VIAL, SINGLE-DOSELIQUID1026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44206-452-02ML - Milliliter44206-45213b617d5-9a55-442b-b1bb-da664052460212012-07-24
44206-452-91ML - Milliliter44206-452755e8772-7f6d-46d3-a6a5-2bec24ac43c812017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSHIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13
Human immunoglobulin GACTIVE MOIETY66Y330CJHSHIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13
HUMAN IMMUNOGLOBULIN AINACTIVE INGREDIENT741C1PWQ88HIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VHIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44206-452HIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]26Current NDC, Legacy NDC, 2 package rows20230429_7b58f5ff-0316-49a3-b585-1f6003ddb953.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809069Hizentra 20 % in 10 ML InjectionPSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268109Hizentra 20 % in 10 ML Prefilled SyringePSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809067Hizentra 20 % in 20 ML InjectionPSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
2287159Hizentra 20 % in 20 ML Prefilled SyringePSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809077Hizentra 20 % in 5 ML InjectionPSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268105Hizentra 20 % in 5 ML Prefilled SyringePSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809063Hizentra 20 % in 50 ML InjectionPSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
2670629Hizentra 20 % in 50 ML Prefilled SyringePSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809068immunoglobulin G, human 20 % in 10 ML InjectionPSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268108immunoglobulin G, human 20 % in 10 ML Prefilled SyringePSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809066immunoglobulin G, human 20 % in 20 ML InjectionPSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
2287158immunoglobulin G, human 20 % in 20 ML Prefilled SyringePSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809076immunoglobulin G, human 20 % in 5 ML InjectionPSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268103immunoglobulin G, human 20 % in 5 ML Prefilled SyringePSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809061immunoglobulin G, human 20 % in 50 ML InjectionPSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
2670628immunoglobulin G, human 20 % in 50 ML Prefilled SyringePSN7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906910 ML immunoglobulin G, human 200 MG/ML Injection [Hizentra]SBD7b58f5ff-0316-49a3-b585-1f6003ddb95326
226810910 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]SBD7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906720 ML immunoglobulin G, human 200 MG/ML Injection [Hizentra]SBD7b58f5ff-0316-49a3-b585-1f6003ddb95326
228715920 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]SBD7b58f5ff-0316-49a3-b585-1f6003ddb95326
18090775 ML immunoglobulin G, human 200 MG/ML Injection [Hizentra]SBD7b58f5ff-0316-49a3-b585-1f6003ddb95326
22681055 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]SBD7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906350 ML immunoglobulin G, human 200 MG/ML Injection [Hizentra]SBD7b58f5ff-0316-49a3-b585-1f6003ddb95326
267062950 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]SBD7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906810 ML immunoglobulin G, human 200 MG/ML InjectionSCD7b58f5ff-0316-49a3-b585-1f6003ddb95326
226810810 ML immunoglobulin G, human 200 MG/ML Prefilled SyringeSCD7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906620 ML immunoglobulin G, human 200 MG/ML InjectionSCD7b58f5ff-0316-49a3-b585-1f6003ddb95326
228715820 ML immunoglobulin G, human 200 MG/ML Prefilled SyringeSCD7b58f5ff-0316-49a3-b585-1f6003ddb95326
18090765 ML immunoglobulin G, human 200 MG/ML InjectionSCD7b58f5ff-0316-49a3-b585-1f6003ddb95326
22681035 ML immunoglobulin G, human 200 MG/ML Prefilled SyringeSCD7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906150 ML immunoglobulin G, human 200 MG/ML InjectionSCD7b58f5ff-0316-49a3-b585-1f6003ddb95326
267062850 ML immunoglobulin G, human 200 MG/ML Prefilled SyringeSCD7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906910 ML Hizentra 200 MG/ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
226810910 ML Hizentra 200 MG/ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906720 ML Hizentra 200 MG/ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
228715920 ML Hizentra 200 MG/ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
18090775 ML Hizentra 200 MG/ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
22681055 ML Hizentra 200 MG/ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
180906350 ML Hizentra 200 MG/ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809077Hizentra 1 GM per 5 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268105Hizentra 1 GM per 5 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809063Hizentra 10 GM per 50 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2670629Hizentra 10 GM per 50 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809069Hizentra 2 GM per 10 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268109Hizentra 2 GM per 10 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809069Hizentra 20 % per 10 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809067Hizentra 20 % per 20 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809077Hizentra 20 % per 5 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809063Hizentra 20 % per 50 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2670629Hizentra 20 % per 50 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2670629Hizentra 200 MG/ML per 50 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809067Hizentra 4 GM per 20 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2287159Hizentra 4 GM per 20 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809076immunoglobulin G, human 1 GM per 5 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268103immunoglobulin G, human 1 GM per 5 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809061immunoglobulin G, human 10 GM per 50 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2670628immunoglobulin G, human 10 GM per 50 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809068immunoglobulin G, human 2 GM per 10 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809068immunoglobulin G, human 20 % per 10 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268108immunoglobulin G, human 20 % per 10 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809066immunoglobulin G, human 20 % per 20 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2287158immunoglobulin G, human 20 % per 20 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809076immunoglobulin G, human 20 % per 5 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2268103immunoglobulin G, human 20 % per 5 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809061immunoglobulin G, human 20 % per 50 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2670628immunoglobulin G, human 20 % per 50 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
2670628immunoglobulin G, human 200 MG/ML per 50 ML Prefilled SyringeSY7b58f5ff-0316-49a3-b585-1f6003ddb95326
1809066immunoglobulin G, human 4 GM per 20 ML InjectionSY7b58f5ff-0316-49a3-b585-1f6003ddb95326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44206-452-02442060452021 VIAL, SINGLE-DOSE in 1 CARTON (44206-452-02) / 10 mL in 1 VIAL, SINGLE-DOSE (44206-452-91) 2011-10-030000-00-00NoNoCurrent
44206-452-914420604529110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical