Albumin (Human)

Product NDC: 67467-633
11-digit product format: 674670633
Labeler code: 67467
Product ID: 67467-633_7fc09e55-b28d-9197-a808-a6b341102f06
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: 200 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67467-633-01	2019-10-21	C162847	48780-1	956f9ecf-d482-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use ALBUMIN (HUMAN) 20% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 20%. ALBUMIN (HUMAN) 20% For intravenous use only 20% solution Initial U.S. Approval: 2006
67467-633-02	2019-10-21	C162847	48780-1	956f9ecf-d482-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use ALBUMIN (HUMAN) 20% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 20%. ALBUMIN (HUMAN) 20% For intravenous use only 20% solution Initial U.S. Approval: 2006

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67467-633-01	Albumin (Human)	50 mL in 1 BOTTLE, GLASS	SOLUTION	50		5
67467-633-02	Albumin (Human)	100 mL in 1 BOTTLE, GLASS	SOLUTION	100		5

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.]	5
ALBUMIN (HUMAN)	ACTIVE MOIETY	ZIF514RVZR	ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]	5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67467-633	ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]	5	Legacy NDC, 2 package rows	20100722_90f0c351-3977-2b84-0a6a-e9cb091430ca.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	90f0c351-3977-2b84-0a6a-e9cb091430ca	5
1741290	albumin human 20 % in 50 ML Injection	PSN	90f0c351-3977-2b84-0a6a-e9cb091430ca	5
1741295	100 ML albumin human, USP 200 MG/ML Injection	SCD	90f0c351-3977-2b84-0a6a-e9cb091430ca	5
1741290	50 ML albumin human, USP 200 MG/ML Injection	SCD	90f0c351-3977-2b84-0a6a-e9cb091430ca	5
1741290	albumin human 10 GM per 50 ML Injection	SY	90f0c351-3977-2b84-0a6a-e9cb091430ca	5
1741295	albumin human 20 % per 100 ML Injection	SY	90f0c351-3977-2b84-0a6a-e9cb091430ca	5
1741290	albumin human 20 % per 50 ML Injection	SY	90f0c351-3977-2b84-0a6a-e9cb091430ca	5
1741295	albumin human 20 GM per 100 ML Injection	SY	90f0c351-3977-2b84-0a6a-e9cb091430ca	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67467-633-01	67467063301	50 mL in 1 BOTTLE, GLASS	50 ml	Historical
67467-633-02	67467063302	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	5