Plasbumin

Product NDC
13533-690
11-digit product format
135330690
Labeler code
13533
Product ID
13533-690_21a20866-f2c2-4b6d-9a3f-acd2cc1b9f4a
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
2.5 g/50mL
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 HUMAN2.5 g/50mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-690-20Plasbumin1 in 1 CARTONSOLUTION115
13533-690-21Plasbumin50 mL in 1 VIALSOLUTION5015
13533-690-25Plasbumin1 in 1 CARTONSOLUTION115
13533-690-26Plasbumin250 mL in 1 VIALSOLUTION25015
13533-690-27Plasbumin1 in 1 CARTONSOLUTION115
13533-690-28Plasbumin500 mL in 1 VIALSOLUTION50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-690-20ML - Milliliter13533-69035f8cdc1-7219-4146-90f5-e8b21d3939c512012-07-24
13533-690-21ML - Milliliter13533-690aea81770-c660-4730-b577-ed66f05ba76c12014-01-04
13533-690-25ML - Milliliter13533-6907b4e7158-2824-48c4-91fa-591f53dd528912012-07-24
13533-690-26ML - Milliliter13533-6903915201c-90bc-4c43-a424-ea3316af1b3212014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albumin (human)ACTIVE INGREDIENTZIF514RVZRPLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]6
Albumin (human)ACTIVE MOIETYZIF514RVZRPLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-690PLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]15Current NDC, Legacy NDC, 6 package rows20221206_ead60f3e-9dcc-7afe-2220-4f2381f3c140.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741420albumin human 5 % in 250 ML InjectionPSNead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741403albumin human 5 % in 50 ML InjectionPSNead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741423albumin human 5 % in 500 ML InjectionPSNead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742228Plasbumin 5 % in 250 ML InjectionPSNead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742329Plasbumin 5 % in 50 ML InjectionPSNead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742330Plasbumin 5 % in 500 ML InjectionPSNead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742228250 ML albumin human, USP 50 MG/ML Injection [Plasbumin]SBDead60f3e-9dcc-7afe-2220-4f2381f3c14015
174232950 ML albumin human, USP 50 MG/ML Injection [Plasbumin]SBDead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742330500 ML albumin human, USP 50 MG/ML Injection [Plasbumin]SBDead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741420250 ML albumin human, USP 50 MG/ML InjectionSCDead60f3e-9dcc-7afe-2220-4f2381f3c14015
174140350 ML albumin human, USP 50 MG/ML InjectionSCDead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741423500 ML albumin human, USP 50 MG/ML InjectionSCDead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741420albumin human 12.5 GM per 250 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741403albumin human 2.5 GM per 50 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741423albumin human 25 GM per 500 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741420albumin human 5 % per 250 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741403albumin human 5 % per 50 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1741423albumin human 5 % per 500 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742228Plasbumin 12.5 GM per 250 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742329Plasbumin 2.5 GM per 50 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742330Plasbumin 25 GM per 500 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742228Plasbumin 5 % per 250 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742329Plasbumin 5 % per 50 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015
1742330Plasbumin 5 % per 500 ML InjectionSYead60f3e-9dcc-7afe-2220-4f2381f3c14015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-690-20135330690201 VIAL in 1 CARTON (13533-690-20) / 50 mL in 1 VIAL (13533-690-21) 1 vial1994-09-260000-00-00NoNoCurrent
13533-690-211353306902150 mL in 1 VIAL50 mlHistorical
13533-690-25135330690251 VIAL in 1 CARTON (13533-690-25) / 250 mL in 1 VIAL (13533-690-26) 1 vial1994-09-260000-00-00NoNoCurrent
13533-690-2613533069026250 mL in 1 VIAL250 mlHistorical
13533-690-27135330690271 VIAL in 1 CARTON (13533-690-27) / 500 mL in 1 VIAL (13533-690-28) 1 vial1994-09-260000-00-00NoNoCurrent
13533-690-2813533069028500 mL in 1 VIAL500 mlHistorical