HUMAN ALBUMIN GRIFOLS

Product NDC
61953-0002
11-digit product format
619530002
Labeler code
61953
Product ID
61953-0002_6bd34851-83d8-4c9e-9892-8b6118e0573f
Type
PLASMA DERIVATIVE
Nonproprietary name
ALBUMIN (HUMAN)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA103352
Marketing category
BLA
Marketing start
2003-06-11
Marketing end
0000-00-00
Substance
ALBUMIN HUMAN
Active strength
13 g/50mL
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61953-0002-1ML - Milliliter61953-0002f32560a4-0608-43c8-b88a-0becabe70e6212012-07-24
61953-0002-2ML - Milliliter61953-00023b0d9aa1-11e7-485d-8d49-77c16966e28212013-02-13
61953-0002-3ML - Milliliter61953-000201bdd374-3df8-434e-9c50-db90fc81d6eb12014-10-03
61953-0002-4ML - Milliliter61953-000266aba513-36cf-4807-951a-23532ee522c012014-10-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61953-0002-1619530002011 VIAL in 1 CARTON (61953-0002-1) > 50 mL in 1 VIAL (61953-0002-3) 1 vial2003-06-110000-00-00NoNoCurrent
61953-0002-2619530002021 VIAL in 1 CARTON (61953-0002-2) > 100 mL in 1 VIAL (61953-0002-4) 1 vial2003-06-110000-00-00NoNoCurrent