FDA.reportPublic FDA data

XEMBIFY

Product NDC
13533-810
11-digit product format
135330810
Labeler code
13533
Product ID
13533-810_3d491d8b-7fa0-47e4-bec0-4fe6d944fa25
Type
PLASMA DERIVATIVE
Nonproprietary name
immune globulin subcutaneous, human-klhw
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
GRIFOLS USA, LLC
Application
BLA125683
Marketing category
BLA
Marketing start
2019-07-03
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
XEMBIFY
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
13533-810-05XEMBIFY1 in 1 CARTONSOLUTION112
13533-810-06XEMBIFY5 mL in 1 VIALSOLUTION512
13533-810-10XEMBIFY1 in 1 CARTONSOLUTION112
13533-810-11XEMBIFY10 mL in 1 VIALSOLUTION1012
13533-810-20XEMBIFY1 in 1 CARTONSOLUTION112
13533-810-21XEMBIFY20 mL in 1 VIALSOLUTION2012
13533-810-50XEMBIFY1 in 1 CARTONSOLUTION112
13533-810-51XEMBIFY50 mL in 1 VIALSOLUTION5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-810-05ML - Milliliter13533-810642633fd-947b-48a2-af62-2e8e27fee45f12019-10-07
13533-810-06ML - Milliliter13533-8105f65762a-8e40-4875-9352-7d3094820ce712019-10-07
13533-810-10ML - Milliliter13533-8101d855bc1-cd67-4608-aa8a-94d2ab6052d312019-10-07
13533-810-11ML - Milliliter13533-810914b1894-2e6a-463c-873e-b07eb29c507d12019-10-07
13533-810-20ML - Milliliter13533-810612e51aa-9f8d-40a2-b76a-f16bc1306b1612019-10-07
13533-810-21ML - Milliliter13533-810537ae1ac-46df-4e8a-bbee-75ee9ffac42812019-10-07
13533-810-50ML - Milliliter13533-810426532a9-9b8a-477b-9de1-5cad108b412b12019-10-07
13533-810-51ML - Milliliter13533-810f41299a4-d44f-48f1-96f2-b2cb65899f1012019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-810XEMBIFY (IMMUNE GLOBULIN SUBCUTANEOUS, HUMAN-KLHW) SOLUTION [GRIFOLS USA, LLC]12Current NDC, Legacy NDC, 8 package rows20250322_8c174b11-a061-412e-a3b2-7bf7e1adaace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2196292immune globulin subcutaneous (human) - klhw 20 % (1 GM in 5 ML) InjectionPSN8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196492immune globulin subcutaneous (human) - klhw 20 % (10 GM in 50 ML) InjectionPSN8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196390immune globulin subcutaneous (human) - klhw 20 % (2 GM in 10 ML) InjectionPSN8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196490immune globulin subcutaneous (human) - klhw 20 % (4 GM in 20 ML) InjectionPSN8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196297Xembify 20 % (1 GM in 5 ML) InjectionPSN8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196493Xembify 20 % (10 GM in 50 ML) InjectionPSN8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196391Xembify 20 % (2 GM in 10 ML) InjectionPSN8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196491Xembify 20 % (4 GM in 20 ML) InjectionPSN8c174b11-a061-412e-a3b2-7bf7e1adaace12
219639110 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]SBD8c174b11-a061-412e-a3b2-7bf7e1adaace12
219649120 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]SBD8c174b11-a061-412e-a3b2-7bf7e1adaace12
21962975 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]SBD8c174b11-a061-412e-a3b2-7bf7e1adaace12
219649350 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]SBD8c174b11-a061-412e-a3b2-7bf7e1adaace12
219639010 ML immune globulin subcutaneous (human) - klhw 200 MG/ML InjectionSCD8c174b11-a061-412e-a3b2-7bf7e1adaace12
219649020 ML immune globulin subcutaneous (human) - klhw 200 MG/ML InjectionSCD8c174b11-a061-412e-a3b2-7bf7e1adaace12
21962925 ML immune globulin subcutaneous (human) - klhw 200 MG/ML InjectionSCD8c174b11-a061-412e-a3b2-7bf7e1adaace12
219649250 ML immune globulin subcutaneous (human) - klhw 200 MG/ML InjectionSCD8c174b11-a061-412e-a3b2-7bf7e1adaace12
219639110 ML Xembify 200 MG/ML InjectionSY8c174b11-a061-412e-a3b2-7bf7e1adaace12
219649120 ML Xembify 200 MG/ML InjectionSY8c174b11-a061-412e-a3b2-7bf7e1adaace12
21962975 ML Xembify 200 MG/ML InjectionSY8c174b11-a061-412e-a3b2-7bf7e1adaace12
219649350 ML Xembify 200 MG/ML InjectionSY8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196297Xembify 20 % (1 GM per 5 ML) InjectionSY8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196493Xembify 20 % (10 GM per 50 ML) InjectionSY8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196391Xembify 20 % (2 GM per 10 ML) InjectionSY8c174b11-a061-412e-a3b2-7bf7e1adaace12
2196491Xembify 20 % (4 GM per 20 ML) InjectionSY8c174b11-a061-412e-a3b2-7bf7e1adaace12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-810-05135330810051 VIAL in 1 CARTON (13533-810-05) / 5 mL in 1 VIAL (13533-810-06) 1 vial2019-07-030000-00-00NoNoCurrent
13533-810-06135330810065 mL in 1 VIAL5 mlHistorical
13533-810-10135330810101 VIAL in 1 CARTON (13533-810-10) / 10 mL in 1 VIAL (13533-810-11) 1 vial2019-07-030000-00-00NoNoCurrent
13533-810-111353308101110 mL in 1 VIAL10 mlHistorical
13533-810-20135330810201 VIAL in 1 CARTON (13533-810-20) / 20 mL in 1 VIAL (13533-810-21) 1 vial2019-07-030000-00-00NoNoCurrent
13533-810-211353308102120 mL in 1 VIAL20 mlHistorical
13533-810-50135330810501 VIAL in 1 CARTON (13533-810-50) / 50 mL in 1 VIAL (13533-810-51) 1 vial2019-07-030000-00-00NoNoCurrent
13533-810-511353308105150 mL in 1 VIAL50 mlHistorical