ALBUMINAR-20 (albumin- human solution

Albuminar-20 by

Drug Labeling and Warnings

Albuminar-20 by is a Other medication manufactured, distributed, or labeled by CSL Behring LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - 50 mL Vial Label

NDC: 0053-7695-90

20%

50 mL

Albumin (Human)
USP 20%
Albuminar®-20

Store between 20-25°C (68-77°F);
excursions permitted to 15-30°C (59-86°F)
[See USP Controlled Room Temperature].

Rx only
I.V. use only

Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767

PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton

NDC: 0053-7695-33

20%

50 mL

Albumin (Human)
USP 20%
Albuminar®-20

For Intravenous Administration Only.

10 g in 50 mL solution osmotically equivalent to
200 mL of plasma.

Do not use if turbid.

Do not begin administration more than 4 hours
after the container has been entered.

Store between 20-25°C (68-77°F); excursions
permitted to 15-30°C (59-86°F) [See USP
Controlled Room Temperature].

Rx only

Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767

CSL Behring

INGREDIENTS AND APPEARANCE

ALBUMINAR-20 
albumin (human) solution

Product Information
Product Type	PLASMA DERIVATIVE	Item Code (Source)	NDC: 0053-7695
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)	Albumin Human	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
sodium chloride (UNII: 451W47IQ8X)
Sodium bicarbonate (UNII: 8MDF5V39QO)
Sodium hydroxide (UNII: 55X04QC32I)
Acetic Acid (UNII: Q40Q9N063P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0053-7695-33	1 in 1 CARTON
1	NDC: 0053-7695-90	50 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
2	NDC: 0053-7695-34	1 in 1 CARTON
2	NDC: 0053-7695-91	100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		01/06/2009	09/07/2022

Labeler - CSL Behring LLC (058268293)

Establishment
Name	Address	ID/FEI	Business Operations
CSL Behring LLC		058268293	MANUFACTURE