NDC Code(s) : 68516-5216-3, 68516-5216-1, 68516-5216-4, 68516-5216-2, 68516-5216-6, 68516-5216-5
Packager : GRIFOLS USA, LLC

Category : PLASMA DERIVATIVE

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALBUTEINALBUMIN (HUMAN) INJECTION, SOLUTION
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:68516-5216
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albumin Human(UNII: ZIF514RVZR)
(Albumin Human - UNII:ZIF514RVZR) 		Albumin Human12.5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride(UNII: 451W47IQ8X)
Sodium Caprylate(UNII: 9XTM81VK2B)
Sodium Acetyltryptophanate(UNII: 3EN9H0M2FX)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68516-5216-11 in 1 CARTON
1NDC:68516-5216-350 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:68516-5216-21 in 1 CARTON
2NDC:68516-5216-4100 mL in 1 VIAL Type 0: Not a Combination Product
3NDC:68516-5216-51 in 1 CARTON
3NDC:68516-5216-620 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102478 03/01/2022

LABELER - GRIFOLS USA, LLC(048987452)

Establishment
Name Address ID/FEI Business Operations
Grifols Biologicals LLC 092694538 manufacture(68516-5216)

Establishment
Name Address ID/FEI Business Operations
Grifols Biologicals LLC 121076871 manufacture(68516-5216)

Establishment
Name Address ID/FEI Business Operations
Grifols Therapeutics LLC 611019113 manufacture(68516-5216)

Establishment
Name Address ID/FEI Business Operations
INSTITUTO GRIFOLS SA 465562213 manufacture(68516-5216)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 50 mL Vial Label

NDC 68516-5216-3              12.5 g  / 50 mL

Albumin (Human)
U.S.P.
Albutein® 25%

Solution

25%       Rx Only

Precautions: Do not allow to freeze. Single dose container for intravenous administration.
Discard any unused contents and administration devices after use. In case of dehydration,
administer additional fluids with or immediately following Albutein®.

Instructions: The patient and physician should discuss the risks and benefits of this product.
For information on dosage and directions for administration, see accompanying pamphlet.

Contents: Each 50 mL contains 12.5 grams Albumin (Human) in aqueous diluent.
Osmotically equivalent to 250 mL of plasma. Sodium range 130-160 milliequivalents per liter.

Contains no preservatives. Heat-treated at 60 °C for 10 hours.
Store at temperatures not exceeding 30 °C. DO NOT USE IF TURBID. DO NOT BEGIN
ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

Grifols Biologicals LLC Los Angeles, CA 90032, USA                          U.S. License No. 1694

Lot No.:

Expires: 

3063718

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 50 mL Carton Label

NDC 68516-5216-1         12.5 g / 50 mL

Albumin (Human)
U.S.P.
Albutein® 25%

Solution 

25%

Store at temperature
not exceeding 30° C.

Rx only

Precautions:
Do not allow to freeze.
Single dose container for intravenous
administration.
Discard any unused contents and
administration devices after use.
In case of dehydration, administer
additional fluids with or immediately
following Albutein®.

Instructions:
The patient and physician should discuss
the risks and benefits of this product. For
information on dosage and directions for
administration, see enclosed pamphlet.

DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER
HAS BEEN ENTERED.

 Contents:
One 50 mL vial Albumin (Human) U.S.P.
Albutein®. Each 50 mL contains 12.5 grams
Albumin (Human) in aqueous diluent.
Osmotically equivalent to 250 mL of plasma.
Sodium range 130-160 milliequivalents
per liter.
Stabilized with 0.08 millimole sodium
caprylate and 0.08 millimole sodium
acetyltryptophanate per gram of albumin.
Contains no preservatives.
Heat-treated at 60 °C for 10 hours.

Grifols Biologicals LLC
Los Angeles, CA 90032, USA
U.S. License No. 1694

GTIN 00368516521618
LOT XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXXXXXXXX

3063716

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 100 mL Vial Label

NDC 68516-5216-4           25 g  / 100 mL

Albumin (Human)   
U.S.P.
Albutein® 25%

Solution

25% 

GRIFOLS                 Rx only

Precautions: Do not allow to freeze. Single dose container for
intravenous administration. Discard any unused contents and
administration devices after use. In case of dehydration, administer
additional fluids with or immediately following Albutein®.

Instructions: The patient and physician should discuss the risks and
benefits of this product. For information on dosage and directions for
administration, see accompanying pamphlet.

Contents: Each 100 mL contains 25 grams Albumin (Human) in
aqueous diluent. Osmotically equivalent to 500 mL of plasma.
Sodium range 130-160 milliequivalents per liter.

Contains no preservatives. Heat-treated at 60 °C for 10 hours.
Store at temperatures not exceeding 30 °C.

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.


Grifols Biologicals LLC
Los Angeles, CA 90032, USA                              U.S. License No. 1694

Lot No.:

Expires:

3063715

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 100 mL Carton Label

NDC 68516-5216-2           25 g / 100 mL

Albumin (Human)
U.S.P.
Albutein® 25%

Solution

25%

Store at temperatures
not exceeding 30° C.

Rx only

Precautions:
 Do not allow to freeze.
Single dose container for intravenous
administration.
Discard any unused contents and
administration devices after use.
In case of dehydration, administer additional
fluids with or immediately following Albutein®.

Instructions:
The patient and physician should discuss
the risks and benefits of this product. For
information on dosage and directions for
administration, see enclosed pamphlet.

DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER
HAS BEEN ENTERED.

 Contents:
One 100 mL vial Albumin (Human) U.S.P.
Albutein®. Each 100 mL contains 25 grams
Albumin (Human) in aqueous diluent.
Osmotically equivalent to 500 mL of plasma.
Sodium range 130-160 milliequivalents per liter.
Stabilized with 0.08 millimole sodium caprylate
and 0.08 millimole sodium acetyltryptophanate
per gram of albumin.
Contains no preservatives.
Heat-treated at 60 °C for 10 hours.

Grifols Biologicals LLC
Los Angeles, CA 90032, USA
U.S. License No. 1694

GTIN 00368516521625
LOT XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXXXXXXXX

3063714

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 20 mL Vial Label

NDC 68516-5216-6    5 g / 20 mL

Albumin (Human)
U.S.P.
Albutein® 25%

Solution

25%    Rx only

Precautions: Do not allow to freeze. Single dose container for
intravenous administration. Discard any unused contents and
administration devices after use. In case of dehydration, administer
additional fluids with or immediately following Albutein®.

Instructions: The patient and physician should discuss the risks and
benefits of this product. For information on dosage and directions for
administration, see accompanying pamphlet.

Contents: Each 20 mL contains 5 grams Albumin (Human) in
aqueous diluent. Osmotically equivalent to 100 mL of plasma.
Sodium range 130-160 milliequivalents per liter.

Contains no preservatives. Heat-treated at 60 °C for 10 hours.
Store at temperatures not exceeding 30 °C.

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.


Grifols Biologicals LLC
Los Angeles, CA 90032, USA                              U.S. License No. 1694

Lot No.:

Expires:

3064243

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 20 mL Carton Label

NDC 68516-5216-5             5 g / 20 mL    

Albumin (Human)
U.S.P.
Albutein® 25%

Solution 5 g 20 mL

25%

Store at temperatures
not exceeding 30° C.

Rx only

Precautions: Do not allow to freeze.
Single dose container for intravenous
administration.
Discard any unused contents and
administration devices after use.
In case of dehydration, administeradditional fluids with or immediately
following Albutein®.

Instructions:
The patient and physician should
discuss the risks and benefits of this
product. For information on dosage
and directions for administration, see
enclosed pamphlet.

DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION
MORE THAN 4 HOURS AFTER THE
CONTAINER HAS BEEN ENTERED.

Contents:

One 20 mL vial Albumin (Human) U.S.P. Albutein®.
Each 20 mL contains 5 grams Albumin (Human)
in aqueous diluent.
Osmotically equivalent to 100 mL of
plasma.
Sodium range 130-160 milliequivalents
per liter.
Stabilized with 0.08 millimole sodium
caprylate and 0.08 millimole sodium
acetyltryptophanate per gram of
albumin.
Contains no preservatives.
Heat-treated at 60 °C for 10 hours.

Grifols Biologicals LLC
Los Angeles, CA 90032, USA
U.S. License No. 1694

GTIN 00368516521656

LOT XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXXXXXXXX

3064250