Plasbumin

Product NDC: 13533-691
11-digit product format: 135330691
Labeler code: 13533
Product ID: 13533-691_089f1f75-35f2-4ff2-884a-95a1f46f369d
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: 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
13533-691-20	Plasbumin	1 in 1 CARTON	SOLUTION	1	14
13533-691-21	Plasbumin	50 mL in 1 VIAL	SOLUTION	50	14
13533-691-71	Plasbumin	1 in 1 CARTON	SOLUTION	1	14
13533-691-72	Plasbumin	100 mL in 1 VIAL	SOLUTION	100	14

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Albumin (human)	ACTIVE INGREDIENT	ZIF514RVZR	PLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	6
Albumin (human)	ACTIVE MOIETY	ZIF514RVZR	PLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	6

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13533-691	PLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]	14	Current NDC, Legacy NDC, 4 package rows	20221206_5b334e41-5297-540c-5fc1-cd7b845c5685.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	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741290	albumin human 20 % in 50 ML Injection	PSN	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741313	Plasbumin 20 % in 100 ML Injection	PSN	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741311	Plasbumin 20 % in 50 ML Injection	PSN	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741313	100 ML albumin human, USP 200 MG/ML Injection [Plasbumin]	SBD	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741311	50 ML albumin human, USP 200 MG/ML Injection [Plasbumin]	SBD	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741295	100 ML albumin human, USP 200 MG/ML Injection	SCD	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741290	50 ML albumin human, USP 200 MG/ML Injection	SCD	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741290	albumin human 10 GM per 50 ML Injection	SY	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741295	albumin human 20 % per 100 ML Injection	SY	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741290	albumin human 20 % per 50 ML Injection	SY	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741295	albumin human 20 GM per 100 ML Injection	SY	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741311	Plasbumin 10 GM per 50 ML Injection	SY	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741313	Plasbumin 20 % per 100 ML Injection	SY	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741311	Plasbumin 20 % per 50 ML Injection	SY	5b334e41-5297-540c-5fc1-cd7b845c5685	14
1741313	Plasbumin 20 GM per 100 ML Injection	SY	5b334e41-5297-540c-5fc1-cd7b845c5685	14

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13533-691-20	13533069120	1 VIAL in 1 CARTON (13533-691-20) / 50 mL in 1 VIAL (13533-691-21)	1 vial	1994-09-26	0000-00-00	No	No	Current
13533-691-21	13533069121	50 mL in 1 VIAL	50 ml					Historical
13533-691-71	13533069171	1 VIAL in 1 CARTON (13533-691-71) / 100 mL in 1 VIAL (13533-691-72)	1 vial	1994-09-26	0000-00-00	No	No	Current
13533-691-72	13533069172	100 mL in 1 VIAL	100 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albumin (Human) 20%, USP Plasbumin ® -20	GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC	2022-11-18	PLASMA DERIVATIVE	14