FDA.reportPublic FDA data

Albuked

Product NDC
76125-792
11-digit product format
761250792
Labeler code
76125
Product ID
76125-792_b3da7fba-1de6-4ec3-bf9c-63ef9e041278
Type
PLASMA DERIVATIVE
Nonproprietary name
Albumin (Human)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
KEDRION BIOPHARMA, INC.
Application
BLA101138
Marketing category
BLA
Marketing start
1942-10-21
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
Albuked
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
76125-792-10Albuked1 in 1 CARTONSOLUTION17
76125-792-11Albuked100 mL in 1 VIALSOLUTION1007
76125-792-20Albuked1 in 1 CARTONSOLUTION17
76125-792-21Albuked20 mL in 1 VIALSOLUTION207
76125-792-25Albuked1 in 1 CARTONSOLUTION17
76125-792-26Albuked50 mL in 1 VIALSOLUTION507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76125-792-10ML - Milliliter76125-792bbd470f1-dae8-4861-987c-6d1d1a3e7ec412018-08-13
76125-792-11ML - Milliliter76125-792b3128bf4-809f-4eac-87dc-e148f9c4ede612018-08-13
76125-792-25ML - Milliliter76125-792facb884a-ab55-48ca-9be2-79f5b65d85ab12018-08-13
76125-792-26ML - Milliliter76125-7923dfa5a2a-419f-4d32-8435-f23d5a79e6ac12018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albumin (human)ACTIVE INGREDIENTZIF514RVZRALBUKED (ALBUMIN (HUMAN)) SOLUTION [KEDRION BIOPHARMA, INC]1
Albumin (human)ACTIVE MOIETYZIF514RVZRALBUKED (ALBUMIN (HUMAN)) SOLUTION [KEDRION BIOPHARMA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76125-792ALBUKED (ALBUMIN (HUMAN)) SOLUTION [KEDRION BIOPHARMA, INC.]7Current NDC, Legacy NDC, 6 package rows20200804_face90dc-a227-3ec2-1645-f74eb9dac68c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1742029albuked 25 % in 50 ML InjectionPSN32d7c0ee-8194-4694-9a3b-1ba880da738910
1741375albumin human 25 % in 50 ML InjectionPSN32d7c0ee-8194-4694-9a3b-1ba880da738910
174202950 ML albumin human, USP 250 MG/ML Injection [Albuked]SBD32d7c0ee-8194-4694-9a3b-1ba880da738910
174137550 ML albumin human, USP 250 MG/ML InjectionSCD32d7c0ee-8194-4694-9a3b-1ba880da738910
1742029Albuked 12.5 GM per 50 ML InjectionSY32d7c0ee-8194-4694-9a3b-1ba880da738910
1742029Albuked 25 % per 50 ML InjectionSY32d7c0ee-8194-4694-9a3b-1ba880da738910
1741375albumin human 12.5 GM per 50 ML InjectionSY32d7c0ee-8194-4694-9a3b-1ba880da738910
1741375albumin human 25 % per 50 ML InjectionSY32d7c0ee-8194-4694-9a3b-1ba880da738910
1742031albuked 25 % in 100 ML InjectionPSNface90dc-a227-3ec2-1645-f74eb9dac68c7
1742331albuked 25 % in 20 ML InjectionPSNface90dc-a227-3ec2-1645-f74eb9dac68c7
1742029albuked 25 % in 50 ML InjectionPSNface90dc-a227-3ec2-1645-f74eb9dac68c7
1741380albumin human 25 % in 100 ML InjectionPSNface90dc-a227-3ec2-1645-f74eb9dac68c7
1741570albumin human 25 % in 20 ML InjectionPSNface90dc-a227-3ec2-1645-f74eb9dac68c7
1741375albumin human 25 % in 50 ML InjectionPSNface90dc-a227-3ec2-1645-f74eb9dac68c7
1742031100 ML albumin human, USP 250 MG/ML Injection [Albuked]SBDface90dc-a227-3ec2-1645-f74eb9dac68c7
174233120 ML albumin human, USP 250 MG/ML Injection [Albuked]SBDface90dc-a227-3ec2-1645-f74eb9dac68c7
174202950 ML albumin human, USP 250 MG/ML Injection [Albuked]SBDface90dc-a227-3ec2-1645-f74eb9dac68c7
1741380100 ML albumin human, USP 250 MG/ML InjectionSCDface90dc-a227-3ec2-1645-f74eb9dac68c7
174157020 ML albumin human, USP 250 MG/ML InjectionSCDface90dc-a227-3ec2-1645-f74eb9dac68c7
174137550 ML albumin human, USP 250 MG/ML InjectionSCDface90dc-a227-3ec2-1645-f74eb9dac68c7
1742029Albuked 12.5 GM per 50 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1742031Albuked 25 % per 100 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1742331Albuked 25 % per 20 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1742029Albuked 25 % per 50 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1742031Albuked 25 GM per 100 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1742331Albuked 5 GM per 20 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1741375albumin human 12.5 GM per 50 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1741380albumin human 25 % per 100 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1741570albumin human 25 % per 20 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1741375albumin human 25 % per 50 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1741380albumin human 25 GM per 100 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7
1741570albumin human 5 GM per 20 ML InjectionSYface90dc-a227-3ec2-1645-f74eb9dac68c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76125-792-10761250792101 VIAL in 1 CARTON (76125-792-10) / 100 mL in 1 VIAL (76125-792-11) 1 vial1942-10-210000-00-00NoNoCurrent
76125-792-1176125079211100 mL in 1 VIAL100 mlHistorical
76125-792-20761250792201 VIAL in 1 CARTON (76125-792-20) / 20 mL in 1 VIAL (76125-792-21) 1 vial1942-10-210000-00-00NoNoCurrent
76125-792-217612507922120 mL in 1 VIAL20 mlHistorical
76125-792-25761250792251 VIAL in 1 CARTON (76125-792-25) / 50 mL in 1 VIAL (76125-792-26) 1 vial1942-10-210000-00-00NoNoCurrent
76125-792-267612507922650 mL in 1 VIAL50 mlHistorical