HUMAN ALBUMIN GRIFOLS

Product NDC: 61953-0002
11-digit product format: 619530002
Labeler code: 61953
Product ID: 61953-0002_6bd34851-83d8-4c9e-9892-8b6118e0573f
Type: PLASMA DERIVATIVE
Nonproprietary name: ALBUMIN (HUMAN)
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: GRIFOLS USA, LLC
Application: BLA103352
Marketing category: BLA
Marketing start: 2003-06-11
Marketing end: 0000-00-00
Substance: ALBUMIN HUMAN
Active strength: 13 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61953-0002		D	Discontinued by firm	2026-08-10
excluded package	package	61953-0002	61953-0002-1	D	Discontinued by firm	2026-08-10
excluded package	package	61953-0002	61953-0002-2	D	Discontinued by firm	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61953-0002-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61953-0002-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61953-0002-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61953-0002-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61953-0002-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61953-0002-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61953-0002-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61953-0002-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61953-0002-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61953-0002-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61953-0002-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61953-0002-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61953-0002-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61953-0002-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61953-0002-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61953-0002-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61953-0002-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61953-0002-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61953-0002-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61953-0002-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61953-0002-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61953-0002-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61953-0002-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61953-0002-2	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61953-0002-1	ML - Milliliter	61953-0002	f32560a4-0608-43c8-b88a-0becabe70e62	1	2012-07-24
61953-0002-2	ML - Milliliter	61953-0002	3b0d9aa1-11e7-485d-8d49-77c16966e282	1	2013-02-13
61953-0002-3	ML - Milliliter	61953-0002	01bdd374-3df8-434e-9c50-db90fc81d6eb	1	2014-10-03
61953-0002-4	ML - Milliliter	61953-0002	66aba513-36cf-4807-951a-23532ee522c0	1	2014-10-03

DailyMed Socrata Ingredients#

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103352	Human Albumin Grifols	Albumin (Human)	351(a)	Disc	2026-06-01

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61953-0002-1	61953000201	1 VIAL in 1 CARTON (61953-0002-1) > 50 mL in 1 VIAL (61953-0002-3)	1 vial	2003-06-11	0000-00-00	No	No	Current
61953-0002-2	61953000202	1 VIAL in 1 CARTON (61953-0002-2) > 100 mL in 1 VIAL (61953-0002-4)	1 vial	2003-06-11	0000-00-00	No	No	Current

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	2022-12-05	PLASMA DERIVATIVE	13