Albuked

Product NDC: 76125-791
11-digit product format: 761250791
Labeler code: 76125
Product ID: 76125-791_0d86d9cc-a63a-4905-9620-deb24eed170e
Type: PLASMA DERIVATIVE
Nonproprietary name: Albumin (Human)
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: KEDRION BIOPHARMA, INC.
Application: BLA101138
Marketing category: BLA
Marketing start: 1981-07-28
Substance: ALBUMIN HUMAN
Active strength: 10 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	10 g/50mL

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76125-791-10	Albuked	1 in 1 CARTON	SOLUTION	1	7
76125-791-11	Albuked	100 mL in 1 VIAL	SOLUTION	100	7
76125-791-50	Albuked	1 in 1 CARTON	SOLUTION	1	7
76125-791-51	Albuked	50 mL in 1 VIAL	SOLUTION	50	7

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
76125-791	ALBUKED (ALBUMIN (HUMAN)) SOLUTION [KEDRION BIOPHARMA, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20200804_3d7b50cd-029a-ab08-83dc-8f87ffa22ef1.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
1741296	albuked 20 % in 100 ML Injection	PSN	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741292	albuked 20 % in 50 ML Injection	PSN	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741295	albumin human 20 % in 100 ML Injection	PSN	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741290	albumin human 20 % in 50 ML Injection	PSN	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741296	100 ML albumin human, USP 200 MG/ML Injection [Albuked]	SBD	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741292	50 ML albumin human, USP 200 MG/ML Injection [Albuked]	SBD	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741295	100 ML albumin human, USP 200 MG/ML Injection	SCD	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741290	50 ML albumin human, USP 200 MG/ML Injection	SCD	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741292	Albuked 10 GM per 50 ML Injection	SY	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741296	Albuked 20 % per 100 ML Injection	SY	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741292	Albuked 20 % per 50 ML Injection	SY	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741296	Albuked 20 GM per 100 ML Injection	SY	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741290	albumin human 10 GM per 50 ML Injection	SY	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741295	albumin human 20 % per 100 ML Injection	SY	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741290	albumin human 20 % per 50 ML Injection	SY	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7
1741295	albumin human 20 GM per 100 ML Injection	SY	3d7b50cd-029a-ab08-83dc-8f87ffa22ef1	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76125-791-10	76125079110	1 VIAL in 1 CARTON (76125-791-10) / 100 mL in 1 VIAL (76125-791-11)	1 vial	1981-07-28	0000-00-00	No	No	Current
76125-791-11	76125079111	100 mL in 1 VIAL	100 ml					Historical
76125-791-50	76125079150	1 VIAL in 1 CARTON (76125-791-50) / 50 mL in 1 VIAL (76125-791-51)	1 vial	1981-07-28	0000-00-00	No	No	Current
76125-791-51	76125079151	50 mL in 1 VIAL	50 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albumin (Human) 20%, USP Albuked™ 20	KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC	2020-08-01	PLASMA DERIVATIVE	7