FDA.reportPublic FDA data

Privigen

Product NDC
44206-436
11-digit product format
442060436
Labeler code
44206
Product ID
44206-436_f9f52f8d-e858-44ed-a529-5764c0d2f01e
Type
PLASMA DERIVATIVE
Nonproprietary name
Human Immunoglobulin G
Dosage form
LIQUID
Route
INTRAVENOUS
Labeler
CSL Behring AG
Application
BLA125201
Marketing category
BLA
Marketing start
2009-01-20
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
5 g/50mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Privigen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G5 g/50mL

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
44206-436-05Privigen1 in 1 CARTONLIQUID129
44206-436-90Privigen50 mL in 1 VIAL, GLASSLIQUID5029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44206-436-05ML - Milliliter44206-436a4ce067d-fee0-4e6f-a81e-56f34706f54812012-07-24
44206-436-90ML - Milliliter44206-4367c2c9a41-29dd-4f73-b53c-a3253a82017112017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Human Immunoglobulin GACTIVE INGREDIENT66Y330CJHSPRIVIGEN (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]18
Human Immunoglobulin GACTIVE MOIETY66Y330CJHSPRIVIGEN (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]18
Albumin HumanINACTIVE INGREDIENTZIF514RVZRPRIVIGEN (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]18
Human Immunoglobulin AINACTIVE INGREDIENT741C1PWQ88PRIVIGEN (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]18
prolineINACTIVE INGREDIENT9DLQ4CIU6VPRIVIGEN (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44206-436PRIVIGEN (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]27Current NDC, Legacy NDC, 2 package rows20220413_7e5649da-75be-4a42-8eeb-4aeba562c401.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809421immunoglobulin G, human 10 % in 100 ML InjectionPSN7e5649da-75be-4a42-8eeb-4aeba562c40129
1809444immunoglobulin G, human 10 % in 200 ML InjectionPSN7e5649da-75be-4a42-8eeb-4aeba562c40129
1809524immunoglobulin G, human 10 % in 400 ML InjectionPSN7e5649da-75be-4a42-8eeb-4aeba562c40129
1809414immunoglobulin G, human 10 % in 50 ML InjectionPSN7e5649da-75be-4a42-8eeb-4aeba562c40129
1809517privigen 10 % in 100 ML InjectionPSN7e5649da-75be-4a42-8eeb-4aeba562c40129
1809520privigen 10 % in 200 ML InjectionPSN7e5649da-75be-4a42-8eeb-4aeba562c40129
1809525privigen 10 % in 400 ML InjectionPSN7e5649da-75be-4a42-8eeb-4aeba562c40129
1809521privigen 10 % in 50 ML InjectionPSN7e5649da-75be-4a42-8eeb-4aeba562c40129
1809517100 ML immunoglobulin G, human 100 MG/ML Injection [Privigen]SBD7e5649da-75be-4a42-8eeb-4aeba562c40129
1809520200 ML immunoglobulin G, human 100 MG/ML Injection [Privigen]SBD7e5649da-75be-4a42-8eeb-4aeba562c40129
1809525400 ML immunoglobulin G, human 100 MG/ML Injection [Privigen]SBD7e5649da-75be-4a42-8eeb-4aeba562c40129
180952150 ML immunoglobulin G, human 100 MG/ML Injection [Privigen]SBD7e5649da-75be-4a42-8eeb-4aeba562c40129
1809421100 ML immunoglobulin G, human 100 MG/ML InjectionSCD7e5649da-75be-4a42-8eeb-4aeba562c40129
1809444200 ML immunoglobulin G, human 100 MG/ML InjectionSCD7e5649da-75be-4a42-8eeb-4aeba562c40129
1809524400 ML immunoglobulin G, human 100 MG/ML InjectionSCD7e5649da-75be-4a42-8eeb-4aeba562c40129
180941450 ML immunoglobulin G, human 100 MG/ML InjectionSCD7e5649da-75be-4a42-8eeb-4aeba562c40129
1809517100 ML Privigen 100 MG/ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809520200 ML Privigen 100 MG/ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809525400 ML Privigen 100 MG/ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
180952150 ML Privigen 100 MG/ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809421immunoglobulin G, human 10 % per 100 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809444immunoglobulin G, human 10 % per 200 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809524immunoglobulin G, human 10 % per 400 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809414immunoglobulin G, human 10 % per 50 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809421immunoglobulin G, human 10 GM per 100 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809444immunoglobulin G, human 20 GM per 200 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809524immunoglobulin G, human 40 GM per 400 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809414immunoglobulin G, human 5 GM per 50 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809517Privigen 10 % per 100 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809520Privigen 10 % per 200 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809525Privigen 10 % per 400 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809521Privigen 10 % per 50 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809517Privigen 10 GM per 100 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809520Privigen 20 GM per 200 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809525Privigen 40 GM per 400 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129
1809521Privigen 5 GM per 50 ML InjectionSY7e5649da-75be-4a42-8eeb-4aeba562c40129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44206-436-05442060436051 VIAL, GLASS in 1 CARTON (44206-436-05) / 50 mL in 1 VIAL, GLASS (44206-436-90) 2009-01-200000-00-00NoNoCurrent
44206-436-904420604369050 mL in 1 VIAL, GLASS50 mlHistorical