HUMAN ALBUMIN GRIFOLS

Product NDC: 61953-0001
11-digit product format: 619530001
Labeler code: 61953
Product ID: 61953-0001_23b658d2-a395-40f9-b894-1a708b2d12ad
Type: PLASMA DERIVATIVE
Nonproprietary name: ALBUMIN (HUMAN)
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: GRIFOLS USA, LLC
Application: BLA103352
Marketing category: BLA
Marketing start: 1995-02-17
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	Strength	SPL version
61953-0001-2	HUMAN ALBUMIN GRIFOLS	1 in 1 CARTON	SOLUTION	1		16
61953-0001-4	HUMAN ALBUMIN GRIFOLS	100 mL in 1 VIAL	SOLUTION	100		16

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Albumin (Human)	ACTIVE INGREDIENT	ZIF514RVZR	HUMAN ALBUMIN GRIFOLS (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	6
Albumin (Human)	ACTIVE MOIETY	ZIF514RVZR	HUMAN ALBUMIN GRIFOLS (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	6
Sodium Acetyltryptophanate	INACTIVE INGREDIENT	3EN9H0M2FX	HUMAN ALBUMIN GRIFOLS (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	6
Sodium Caprylate	INACTIVE INGREDIENT	9XTM81VK2B	HUMAN ALBUMIN GRIFOLS (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	6
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	HUMAN ALBUMIN GRIFOLS (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	6
Water	INACTIVE INGREDIENT	059QF0KO0R	HUMAN ALBUMIN GRIFOLS (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	6

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61953-0001	HUMAN ALBUMIN GRIFOLS (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	16	Current NDC, Legacy NDC, 2 package rows	20250221_a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc.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
1741295	albumin human 20 % in 100 ML Injection	PSN	a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc	16
1741304	Human Albumin Grifols 20 % in 100 ML Injection	PSN	a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc	16
1741304	100 ML albumin human, USP 200 MG/ML Injection [Human Albumin Grifols]	SBD	a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc	16
1741295	100 ML albumin human, USP 200 MG/ML Injection	SCD	a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc	16
1741295	albumin human 20 % per 100 ML Injection	SY	a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc	16
1741295	albumin human 20 GM per 100 ML Injection	SY	a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc	16
1741304	Human Albumin Grifols 20 % per 100 ML Injection	SY	a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc	16
1741304	Human Albumin Grifols 20 GM per 100 ML Injection	SY	a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc	16

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61953-0001-1	61953000101	1 VIAL in 1 CARTON (61953-0001-1) > 50 mL in 1 VIAL (61953-0001-3)	1 vial	1995-02-17	0000-00-00	No	No	Current
61953-0001-2	61953000102	1 VIAL in 1 CARTON (61953-0001-2) / 100 mL in 1 VIAL (61953-0001-4)	1 vial	1995-02-17	0000-00-00	No	No	Current
61953-0001-4	61953000104	100 mL in 1 VIAL	100 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HUMAN ALBUMIN GRIFOLS	GRIFOLS USA, LLC \| Instituto Grifols, S.A. \| GRIFOLS WORLDWIDE OPERATIONS LIMITED	2025-02-11	PLASMA DERIVATIVE	16