Albumin (Human)

Product NDC: 67467-643
11-digit product format: 674670643
Labeler code: 67467
Product ID: 67467-643_be20e36e-0b6e-7b05-82ac-7078b2befd03
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albumin Human
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Application: BLA125154
Marketing category: BLA
Marketing start: 2006-10-17
Marketing end: 0000-00-00
Substance: ALBUMIN (HUMAN)
Active strength: 250 g/1000mL
Pharmacologic classes: Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	67467-643		I	Inactivated by FDA	2026-08-10
excluded package	package	67467-643	67467-643-01	I	Inactivated by FDA	2026-08-10
excluded package	package	67467-643	67467-643-02	I	Inactivated by FDA	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 2 · 66 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	67467-643-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67467-643-01	`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	67467-643-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67467-643-01	`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	67467-643-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67467-643-01	`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	67467-643-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67467-643-01	`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	67467-643-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67467-643-01	`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	67467-643-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67467-643-01	`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	67467-643-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67467-643-01	`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	67467-643-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67467-643-01	`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	67467-643-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67467-643-01	`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	67467-643-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67467-643-01	`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	67467-643-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67467-643-01	`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	67467-643-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67467-643-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67467-643-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67467-643-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67467-643-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67467-643-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67467-643-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67467-643-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67467-643-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67467-643-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67467-643-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67467-643-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67467-643-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67467-643-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67467-643-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67467-643-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67467-643-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67467-643-01	`e2bbac7714bc…`	`27bdfed8d636…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67467-643-01	2019-10-21	C162847	48780-1	956f9ecf-d2a8-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use ALBUMIN (HUMAN) 25% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 25%. ALBUMIN (HUMAN) 25% For intravenous use only 25% solution Initial U.S. Approval: 2006
67467-643-02	2019-10-21	C162847	48780-1	956f9ecf-d2a8-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use ALBUMIN (HUMAN) 25% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 25%. ALBUMIN (HUMAN) 25% For intravenous use only 25% solution Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67467-643-01	Albumin (Human)	50 mL in 1 BOTTLE, GLASS	SOLUTION	50		4
67467-643-02	Albumin (Human)	100 mL in 1 BOTTLE, GLASS	SOLUTION	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67467-643-01	ML - Milliliter	67467-643	5e9733f4-4fc3-45ed-9661-fc691ab823e4	1	2012-07-24
67467-643-02	ML - Milliliter	67467-643	10d5e8a3-5305-4cab-8806-ac025127d6ac	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ALBUMIN (HUMAN)	ACTIVE INGREDIENT	ZIF514RVZR	ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]	4
ALBUMIN (HUMAN)	ACTIVE MOIETY	ZIF514RVZR	ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67467-643	ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]	4	Legacy NDC, 2 package rows	20100723_4ddaae99-05e1-e05c-e63c-0c58965d157d.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125154		Albumin (Human)	351(a)	Rx	2026-06-01

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1741380	albumin human 25 % in 100 ML Injection	PSN	4ddaae99-05e1-e05c-e63c-0c58965d157d	4
1741375	albumin human 25 % in 50 ML Injection	PSN	4ddaae99-05e1-e05c-e63c-0c58965d157d	4
1741380	100 ML albumin human, USP 250 MG/ML Injection	SCD	4ddaae99-05e1-e05c-e63c-0c58965d157d	4
1741375	50 ML albumin human, USP 250 MG/ML Injection	SCD	4ddaae99-05e1-e05c-e63c-0c58965d157d	4
1741375	albumin human 12.5 GM per 50 ML Injection	SY	4ddaae99-05e1-e05c-e63c-0c58965d157d	4
1741380	albumin human 25 % per 100 ML Injection	SY	4ddaae99-05e1-e05c-e63c-0c58965d157d	4
1741375	albumin human 25 % per 50 ML Injection	SY	4ddaae99-05e1-e05c-e63c-0c58965d157d	4
1741380	albumin human 25 GM per 100 ML Injection	SY	4ddaae99-05e1-e05c-e63c-0c58965d157d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67467-643-01	67467064301	50 mL in 1 BOTTLE, GLASS	50 ml	Historical
67467-643-02	67467064302	100 mL in 1 BOTTLE, GLASS	100 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albumin (Human)	Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.	2008-08-01	HUMAN PRESCRIPTION DRUG LABEL	4