FDA.reportPublic FDA data

Plasbumin

Product NDC
13533-692
11-digit product format
135330692
Labeler code
13533
Product ID
13533-692_38864ce1-9eaf-4d04-bfca-39205b0f1504
Type
PLASMA DERIVATIVE
Nonproprietary name
Albumin (Human)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA101138
Marketing category
BLA
Marketing start
1994-09-26
Substance
ALBUMIN HUMAN
Active strength
5 g/20mL
Pharmacologic classes
Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Plasbumin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUMIN HUMAN5 g/20mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-692-16Plasbumin1 in 1 CARTONSOLUTION116
13533-692-17Plasbumin20 mL in 1 VIALSOLUTION2016
13533-692-20Plasbumin1 in 1 CARTONSOLUTION116
13533-692-21Plasbumin50 mL in 1 VIALSOLUTION5016
13533-692-71Plasbumin1 in 1 CARTONSOLUTION116
13533-692-72Plasbumin100 mL in 1 VIALSOLUTION10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-692-16ML - Milliliter13533-692879169b7-b15a-4b85-9f43-309c9b3d4fd212012-07-24
13533-692-17ML - Milliliter13533-692abb8f58f-0947-4d56-8b36-e0fb2291fe3812013-11-04
13533-692-20ML - Milliliter13533-692f5ecfe01-ff31-4168-9b40-f3eec4f7aed212012-07-24
13533-692-21ML - Milliliter13533-692d1a2e8d6-d370-482b-862b-656bc8be163012013-11-04
13533-692-71ML - Milliliter13533-69254592db4-e02f-4770-b56c-b4cf82909ec512012-07-24
13533-692-72ML - Milliliter13533-692fa2203d9-85d1-44c3-b26b-d931417bde7112013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albumin (human)ACTIVE INGREDIENTZIF514RVZRPLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]8
Albumin (human)ACTIVE MOIETYZIF514RVZRPLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-692PLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]16Current NDC, Legacy NDC, 6 package rows20221206_2eeb6b69-2013-c0a2-5e2f-0365114d41b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741380albumin human 25 % in 100 ML InjectionPSN2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741570albumin human 25 % in 20 ML InjectionPSN2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741375albumin human 25 % in 50 ML InjectionPSN2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742399Plasbumin 25 % in 100 ML InjectionPSN2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742400Plasbumin 25 % in 20 ML InjectionPSN2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742395Plasbumin 25 % in 50 ML InjectionPSN2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742399100 ML albumin human, USP 250 MG/ML Injection [Plasbumin]SBD2eeb6b69-2013-c0a2-5e2f-0365114d41b416
174240020 ML albumin human, USP 250 MG/ML Injection [Plasbumin]SBD2eeb6b69-2013-c0a2-5e2f-0365114d41b416
174239550 ML albumin human, USP 250 MG/ML Injection [Plasbumin]SBD2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741380100 ML albumin human, USP 250 MG/ML InjectionSCD2eeb6b69-2013-c0a2-5e2f-0365114d41b416
174157020 ML albumin human, USP 250 MG/ML InjectionSCD2eeb6b69-2013-c0a2-5e2f-0365114d41b416
174137550 ML albumin human, USP 250 MG/ML InjectionSCD2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741375albumin human 12.5 GM per 50 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741380albumin human 25 % per 100 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741570albumin human 25 % per 20 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741375albumin human 25 % per 50 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741380albumin human 25 GM per 100 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1741570albumin human 5 GM per 20 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742395Plasbumin 12.5 GM per 50 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742399Plasbumin 25 % per 100 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742400Plasbumin 25 % per 20 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742395Plasbumin 25 % per 50 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742399Plasbumin 25 GM per 100 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416
1742400Plasbumin 5 GM per 20 ML InjectionSY2eeb6b69-2013-c0a2-5e2f-0365114d41b416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-692-16135330692161 VIAL in 1 CARTON (13533-692-16) / 20 mL in 1 VIAL (13533-692-17) 1 vial1994-09-260000-00-00NoNoCurrent
13533-692-171353306921720 mL in 1 VIAL20 mlHistorical
13533-692-20135330692201 VIAL in 1 CARTON (13533-692-20) / 50 mL in 1 VIAL (13533-692-21) 1 vial1994-09-260000-00-00NoNoCurrent
13533-692-211353306922150 mL in 1 VIAL50 mlHistorical
13533-692-71135330692711 VIAL in 1 CARTON (13533-692-71) / 100 mL in 1 VIAL (13533-692-72) 1 vial1994-09-260000-00-00NoNoCurrent
13533-692-7213533069272100 mL in 1 VIAL100 mlHistorical