NDC Code(s) : 68516-5215-3, 68516-5215-1, 68516-5215-4, 68516-5215-2
Packager : GRIFOLS USA, LLC
Category : PLASMA DERIVATIVE
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
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| LABELER - GRIFOLS USA, LLC(048987452) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Grifols Biologicals LLC | 092694538 | manufacture(68516-5215) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Grifols Biologicals LLC | 121076871 | manufacture(68516-5215) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Grifols Therapeutics LLC | 611019113 | manufacture(68516-5215) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| INSTITUTO GRIFOLS SA | 465562213 | manufacture(68516-5215) | |
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 50 mL Vial Label
NDC 68516-5215-3 10 g / 50 mL
Albumin (Human)
U.S.P.
Albutein® 20%
Solution
20% 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 10 grams Albumin (Human) in aqueous diluent. Osmotically
equivalent to 200 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.:
GRIFOLS
Albutein® 20%
10 g / 50 mL
Lot No.:
GRIFOLS
Albutein® 20%
10 g / 50 mL
Lot No.:
Expires:
3063723
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 50 mL Carton Label
NDC 68516-5215-1 10 g / 50 mL
Albumin (Human)
U.S.P.
Albutein® 20%
Solution
20%
Store at temperatures
not exceeding 30 °C.
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.
DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER
HAS BEEN ENTERED.
GRIFOLS
Contents:
One 50 mL vial Albumin (Human) U.S.P.
Albutein®. Each 50 mL contains 10 grams
Albumin (Human) in aqueous diluent.
Osmotically equivalent to 200 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
GRIFOLS
3063722
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 100 mL Vial Label
NDC 68516-5215-4 20 g / 100 mL
Albumin (Human)
U.S.P.
Albutein® 20%
Solution
20%
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 20 grams Albumin (Human) in aqueous diluent. Osmotically
equivalent to 400 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.:
GRIFOLS
Albutein® 20%
20 g / 100 mL
Lot No.:
GRIFOLS
Albutein® 20%
20 g / 100 mL
Lot No.:
Expires:
3063721
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 100 mL Carton Label
NDC 68516-5215-2 20 g / 100 mL
Albumin (Human)
U.S.P.
Albutein® 20%
Solution
20%
Store at temperatures not exceeding 30 °C.
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.
DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER
HAS BEEN ENTERED.
GRIFOLS
Contents:
One 100 mL vial Albumin (Human) U.S.P.
Albutein®. Each 100 mL contains 20 grams
Albumin (Human) in aqueous diluent.
Osmotically equivalent to 400 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
GRIFOLS
3063720
