ALBUMINEX
These highlights do not include all the information needed to use ALBUMINEX 25% Albumin (human) - kjda safely and effectively. See full prescribing information for ALBUMINEX 25%. ALBUMINEX 25% (human albumin) solution for injection. Initial U.S. Approval: [2018]
Approved
Approval ID
167f48d0-8ae5-4f7e-b050-9673dad78acc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2023
Manufacturers
FDA
BPL
DUNS: 216845337
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 Code64208-2512
Application NumberBLA125644
Product Classification
M
Marketing Category
C73585
G
Generic Name
Albumin Human
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 15, 2018
FDA Product Classification
INGREDIENTS (5)
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Albumin HumanActive
Quantity: 0.25 g in 1 mL
Code: ZIF514RVZR
Classification: ACTIB
Caprylic AcidInactive
Code: OBL58JN025
Classification: IACT
N-ACETYL-DL-TRYPTOPHAN SODIUMInactive
Code: 3EN9H0M2FX
Classification: IACT