NDC Code(s) : 68516-5214-3, 68516-5214-1, 68516-5214-4, 68516-5214-2, 68516-5214-6, 68516-5214-5
Packager : GRIFOLS USA, LLC
Category : PLASMA DERIVATIVE
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
| ALBUTEINALBUMIN (HUMAN) INJECTION, SOLUTION | ||||||||||||||||||||||||||||||||||||||||
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| LABELER - GRIFOLS USA, LLC(048987452) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Grifols Biologicals LLC | 092694538 | manufacture(68516-5214) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Grifols Biologicals LLC | 121076871 | manufacture(68516-5214) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Grifols Therapeutics LLC | 611019113 | manufacture(68516-5214) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| INSTITUTO GRIFOLS SA | 465562213 | manufacture(68516-5214) | |
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 50 mL Vial Label
NDC 68516-5214-6 2.5 g / 50 mL
Albumin (Human) U.S.P
Albutein® 5%
Solution
5%
Rx Only
Precautions: Do not allow to freeze. Single dose container for intravenous
administration. Discard any unused contents and administration devices
after use.
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 2.5 grams Albumin (Human) in aqueous
diluent. Osmotically and isotonically equivalent to an equal volume of
normal human 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:
3064240
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 50 mL Carton Label
NDC 68516-5214-5 2.5 g / 50 mL
Albumin (Human) U.S.P.
Albutein® 5%
Solution
5%
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.
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.
GRIFOLS
Contents:
One 50 mL vial Albumin (Human) U.S.P.
Albutein®. Each 50 mL contains 2.5 grams
Albumin (Human) in aqueous diluent.
Osmotically and isotonically equivalent to
an equal volume of normal human 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 00368516521458
Lot XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXXXXXXXX
3064248
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 250 mL Vial Label
NDC 68516-5214-3 12.5 g / 250 mL
Albumin (Human)
U.S.P.
Albutein® 5%
Solution
5%
GRIFOLS Rx only
Precautions: Do not allow to freeze. Single dose container for
intravenous administration. Discard any unused contents and
administration devices after use.
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 250 mL contains 12.5 grams Albumin (Human) in
aqueous diluent. Osmotically and isotonically equivalent to an equal
volume of normal human 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:
3063730
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 250 mL Carton Label
NDC 68516-5214-1 12.5 g/ 250 mL
Albumin (Human)
U.S.P.
Albutein® 5%
Solution
5%
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.
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.
GRIFOLS
Contents:
One 250 mL vial Albumin (Human) U.S.P.
Albutein®. Each 250 mL contains 12.5 grams
Albumin (Human) in aqueous diluent.
Osmotically and isotonically equivalent to an
equal volume of normal human 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 00368516521410
LOT XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXXXXXXXX
3063729
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 500 mL Vial Label
NDC 68516-5214-4 25 g / 500 mL
Albumin (Human)
U.S.P.
Albutein® 5%
Solution
5%
GRIFOLS Rx only
Precautions: Do not allow to freeze. Single dose container for
intravenous administration. Discard any unused contents and
administration devices after use.
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 500 mL contains 25 grams Albumin (Human) in
aqueous diluent. Osmotically and isotonically equivalent to an equal
volume of normal human 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:
3063727
PRINCIPAL DISPLAY PANEL
Principal Display Panel – 500 mL Carton Label
NDC 68516-5214-2 25 g / 500 mL
Albumin (Human)
U.S.P.
Albutein® 5%
Solution
5%
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.
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.
GRIFOLS
Contents:
One 500 mL vial Albumin (Human) U.S.P.
Albutein®. Each 500 mL contains 25 grams
Albumin (Human) in aqueous diluent.
Osmotically and isotonically equivalent to an
equal volume of normal human 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 00368516521427
LOT XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXXXXXXXX
3063726
