Albuminar-25

Product NDC: 0053-7680
11-digit product format: 000537680
Labeler code: 0053
Product ID: 0053-7680_93e1b4dc-4da8-4888-b3e1-5efbc9114081
Type: PLASMA DERIVATIVE
Nonproprietary name: Albumin (Human)
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: CSL Behring LLC
Application: BLA103955
Marketing category: BLA
Marketing start: 2009-01-06
Marketing end: 2022-09-17
Substance: ALBUMIN HUMAN
Active strength: 25 g/100mL
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: 0000-00-00
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	0053-7680		D	Discontinued by firm	2026-08-17
excluded package	package	0053-7680	0053-7680-32	D	Discontinued by firm	2026-08-17
excluded package	package	0053-7680	0053-7680-33	D	Discontinued by firm	2026-08-17

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	0053-7680-33	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0053-7680-32	`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	0053-7680-33	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0053-7680-32	`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	0053-7680-33	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0053-7680-32	`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	0053-7680-33	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0053-7680-32	`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	0053-7680-33	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0053-7680-32	`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	0053-7680-33	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0053-7680-32	`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	0053-7680-33	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0053-7680-32	`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	0053-7680-33	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0053-7680-32	`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	0053-7680-33	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0053-7680-32	`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	0053-7680-33	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0053-7680-32	`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	0053-7680-33	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0053-7680-32	`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	0053-7680-33	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0053-7680-32	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0053-7680-32	ML - Milliliter	0053-7680	9a6a60ac-c698-4638-b8dd-e06f29992c51	1	2012-07-24
0053-7680-33	ML - Milliliter	0053-7680	e0e0d594-a764-4724-a4bf-f1903e12ba2b	1	2012-07-24
0053-7680-91	ML - Milliliter	0053-7680	db1e8c31-fda2-45dc-b654-27fd61085b6e	1	2015-05-05
0053-7680-92	ML - Milliliter	0053-7680	5954211b-3fcf-411f-814d-80d0e8ddb37b	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Albumin Human	ACTIVE INGREDIENT	ZIF514RVZR	ALBUMINAR-25 (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING LLC]	7
Albumin Human	ACTIVE MOIETY	ZIF514RVZR	ALBUMINAR-25 (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING LLC]	7
Acetic Acid	INACTIVE INGREDIENT	Q40Q9N063P	ALBUMINAR-25 (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING LLC]	7
Sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	ALBUMINAR-25 (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING LLC]	7
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ALBUMINAR-25 (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING LLC]	7
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ALBUMINAR-25 (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING LLC]	7

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103955	Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	Albumin (Human)	351(a)	Disc	2026-08-01

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0053-7680-32	00053768032	1 VIAL, GLASS in 1 CARTON (0053-7680-32) > 50 mL in 1 VIAL, GLASS (0053-7680-91)	2009-01-06	2022-09-17	No	No	Current
0053-7680-33	00053768033	1 VIAL, GLASS in 1 CARTON (0053-7680-33) > 100 mL in 1 VIAL, GLASS (0053-7680-92)	2009-01-06	2022-09-17	No	No	Current