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Albumin (Human)

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

Approved
Approval ID

4ddaae99-05e1-e05c-e63c-0c58965d157d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 1, 2008

Manufacturers
FDA

Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.

DUNS: 301119178

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Albumin Human

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67467-643
Application NumberBLA125154
Product Classification
M
Marketing Category
C73585
G
Generic Name
Albumin Human
Product Specifications
Route of AdministrationIntravenous
Effective DateAugust 1, 2008
FDA Product Classification

INGREDIENTS (1)

ALBUMIN (HUMAN)Active
Quantity: 250 g in 1000 mL
Code: ZIF514RVZR
Classification: ACTIB

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Albumin (Human) - FDA Drug Approval Details