Albuked

Product NDC: 76125-790
11-digit product format: 761250790
Labeler code: 76125
Product ID: 76125-790_2b3f8934-dbf3-45c0-89c1-616385112b80
Type: PLASMA DERIVATIVE
Nonproprietary name: Albumin (Human)
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: KEDRION BIOPHARMA, INC.
Application: BLA101138
Marketing category: BLA
Marketing start: 1976-08-26
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#

Ingredient, Strength table
Ingredient	Strength
ALBUMIN HUMAN	2.5 g/50mL

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76125-790-05	Albuked	1 in 1 CARTON	SOLUTION	1	7
76125-790-06	Albuked	50 mL in 1 VIAL	SOLUTION	50	7
76125-790-25	Albuked	1 in 1 CARTON	SOLUTION	1	7
76125-790-26	Albuked	250 mL in 1 VIAL	SOLUTION	250	7

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76125-790-25	ML - Milliliter	76125-790	3982cbf3-f299-4093-90e8-6821f69f898c	1	2015-06-09
76125-790-26	ML - Milliliter	76125-790	de6b54f5-d9fc-444e-bb21-0cbef9a72db5	1	2015-06-09

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Albumin (human)	ACTIVE INGREDIENT	ZIF514RVZR	ALBUKED (ALBUMIN (HUMAN)) SOLUTION [KEDRION BIOPHARMA, INC]	1
Albumin (human)	ACTIVE MOIETY	ZIF514RVZR	ALBUKED (ALBUMIN (HUMAN)) SOLUTION [KEDRION BIOPHARMA, INC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76125-790	ALBUKED (ALBUMIN (HUMAN)) SOLUTION [KEDRION BIOPHARMA, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20200804_fac1e3bd-5b30-f251-c5ae-2226caecf51d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZIF514RVZR	ALBUMIN HUMAN	9048-46-8	ALBUMIN HUMAN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1741974	albuked 5 % in 250 ML Injection	PSN	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1742038	albuked 5 % in 50 ML Injection	PSN	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741420	albumin human 5 % in 250 ML Injection	PSN	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741403	albumin human 5 % in 50 ML Injection	PSN	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741974	250 ML albumin human, USP 50 MG/ML Injection [Albuked]	SBD	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1742038	50 ML albumin human, USP 50 MG/ML Injection [Albuked]	SBD	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741420	250 ML albumin human, USP 50 MG/ML Injection	SCD	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741403	50 ML albumin human, USP 50 MG/ML Injection	SCD	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741974	Albuked 12.5 GM per 250 ML Injection	SY	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1742038	Albuked 2.5 GM per 50 ML Injection	SY	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741974	Albuked 5 % per 250 ML Injection	SY	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1742038	Albuked 5 % per 50 ML Injection	SY	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741420	albumin human 12.5 GM per 250 ML Injection	SY	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741403	albumin human 2.5 GM per 50 ML Injection	SY	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741420	albumin human 5 % per 250 ML Injection	SY	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7
1741403	albumin human 5 % per 50 ML Injection	SY	fac1e3bd-5b30-f251-c5ae-2226caecf51d	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76125-790-05	76125079005	1 VIAL in 1 CARTON (76125-790-05) / 50 mL in 1 VIAL (76125-790-06)	1 vial	1976-08-26	0000-00-00	No	No	Current
76125-790-06	76125079006	50 mL in 1 VIAL	50 ml					Historical
76125-790-25	76125079025	1 VIAL in 1 CARTON (76125-790-25) / 250 mL in 1 VIAL (76125-790-26)	1 vial	1976-08-26	0000-00-00	No	No	Current
76125-790-26	76125079026	250 mL in 1 VIAL	250 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albumin (Human) 5%, USP Albuked™ 5	KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC	2020-08-01	PLASMA DERIVATIVE	7