NDC Code(s) : 68516-3607-2, 68516-3610-2, 68516-3608-2, 68516-3611-2, 68516-3609-2, 68516-3612-2
Packager : GRIFOLS USA, LLC

Category : PLASMA DERIVATIVE

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AlphaNine COAGULATION FACTOR IX (HUMAN) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:68516-3607
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
dextrose(UNII: IY9XDZ35W2)
heparin(UNII: T2410KM04A)
sodium chloride(UNII: 451W47IQ8X)
sodium citrate(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68516-3607-21 in 1 CARTON Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103249 12/31/1990
AlphaNine COAGULATION FACTOR IX (HUMAN) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:68516-3610
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
dextrose(UNII: IY9XDZ35W2)
heparin(UNII: T2410KM04A)
sodium chloride(UNII: 451W47IQ8X)
sodium citrate(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68516-3610-21 in 1 CARTON Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103249 12/31/1990
AlphaNine COAGULATION FACTOR IX (HUMAN) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:68516-3608
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
dextrose(UNII: IY9XDZ35W2)
heparin(UNII: T2410KM04A)
sodium chloride(UNII: 451W47IQ8X)
sodium citrate(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68516-3608-21 in 1 CARTON Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103249 12/31/1990
AlphaNine COAGULATION FACTOR IX (HUMAN) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:68516-3611
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
dextrose(UNII: IY9XDZ35W2)
heparin(UNII: T2410KM04A)
sodium chloride(UNII: 451W47IQ8X)
sodium citrate(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68516-3611-21 in 1 CARTON Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103249 12/31/1990
AlphaNine COAGULATION FACTOR IX (HUMAN) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:68516-3609
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
dextrose(UNII: IY9XDZ35W2)
heparin(UNII: T2410KM04A)
sodium chloride(UNII: 451W47IQ8X)
sodium citrate(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68516-3609-21 in 1 CARTON Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103249 12/31/1990
AlphaNine COAGULATION FACTOR IX (HUMAN) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:68516-3612
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
dextrose(UNII: IY9XDZ35W2)
heparin(UNII: T2410KM04A)
sodium chloride(UNII: 451W47IQ8X)
sodium citrate(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68516-3612-21 in 1 CARTON Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103249 12/31/1990

LABELER - GRIFOLS USA, LLC(048987452)

Establishment
Name Address ID/FEI Business Operations
Grifols Biologicals LLC 092694538 manufacture(68516-3606, 68516-3605, 68516-3607, 68516-3608, 68516-3609, 68516-3610, 68516-3611, 68516-3612)

Establishment
Name Address ID/FEI Business Operations
Grifols Biologicals LLC 121076871 manufacture(68516-3604, 68516-3605, 68516-3606, 68516-3607, 68516-3608, 68516-3609, 68516-3610, 68516-3611, 68516-3612)

Establishment
Name Address ID/FEI Business Operations
LABORATORIOS GRIFOLS SA 463719725 manufacture(68516-1002, 76297-002)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 500 IU Vial Label

NDC 68516-3604-2          500 IU FIX Range    

Coagulation Factor IX (Human)
AlphaNine® SD
Solvent Detergent Treated / Virus
Filtered
Storage: Store between 2 and 8 °C.
May be stored at room temperature
not to exceed 30 °C for 1 month.
Rx Only. Single dose container for
intravenous administration only.

U.S. License No. 1694            10 mL

Instructions: Reconstitute with 10 mL
Sterile Water for Injection, USP.
Administer promptly after
reconstitution and do not refrigerate.
Discard unused contents. For
information on dosage and
directions for administration, see
accompanying pamphlet. Contains
no preservatives. The patient and
physician should discuss the risks
and benefits of this product.
Grifols Biologicals LLC
5555 Valley Boulevard,
Los Angeles, CA 90032, U.S.A.

Lot

EXP

IU FIX/Vial                              3063701

Lot

IU FIX/Vial

Alphanine® SD
10 mL NDC 68516-3604-2

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 1000 IU Vial Label


NDC 68516-3605-2          1000 IU FIX Range  

Coagulation Factor IX (Human)
AlphaNine® SD
Solvent Detergent Treated / Virus
Filtered
Storage: Store between 2 and 8 °C.
May be stored at room temperature
not to exceed 30 °C for 1 month.
Rx Only. Single dose container for
intravenous administration only.

U.S. License No. 1694            10 mL

Instructions: Reconstitute with 10 mL
Sterile Water for Injection, USP.
Administer promptly after
reconstitution and do not refrigerate.
Discard unused contents. For
information on dosage and
directions for administration, see
accompanying pamphlet. Contains
no preservatives. The patient and
physician should discuss the risks
and benefits of this product.
Grifols Biologicals LLC
5555 Valley Boulevard,
Los Angeles, CA 90032, U.S.A.

Lot

EXP 

IU FIX/Vial                              3063699

Lot

IU FIX/Vial

Alphanine® SD
10 mL NDC 68516-3605-2

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 1500 IU Vial Label

NDC 68516-3606-2          1500 IU FIX Range  

Coagulation Factor IX (Human)
AlphaNine® SD
Solvent Detergent Treated / Virus
Filtered
Storage: Store between 2 and 8 °C.
May be stored at room temperature
not to exceed 30 °C for 1 month.
Rx Only. Single dose container for
intravenous administration only.

U.S. License No. 1694            10 mL

Instructions: Reconstitute with 10 mL
Sterile Water for Injection, USP.
Administer promptly after
reconstitution and do not refrigerate.
Discard unused contents. For
information on dosage and
directions for administration, see
accompanying pamphlet. Contains
no preservatives. The patient and
physician should discuss the risks
and benefits of this product.
Grifols Biologicals LLC
5555 Valley Boulevard,
Los Angeles, CA 90032, U.S.A.

Lot

EXP 

IU FIX/Vial                              3063697

Lot

IU FIX/Vial

Alphanine® SD
10 mL NDC 68516-3606-2

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 500 IU Carton Label

NDC 68516-3610-2      500 IU FIX Range

Coagulation Factor IX (Human)
AlphaNine® SD

Solvent Detergent Treated / Virus Filtered

Rx only
For Intravenous Administration          10 mL 

GRIFOLS

Contents:
One vial Coagulation Factor IX (Human), AlphaNine®
SD, one vial 10 mL Sterile Water for Injection, USP,
one Mix2Vial® filter transfer set, and directions for
use.

For intravenous administration.

The reconstituted product contains not more than
0.04 unit of heparin, and not more than 0.2 mg of
dextrose, and not more than 1.0 µg polysorbate 80
and 0.10 µg tri(n-butyl) phosphate per IU of Factor IX.

Contains no preservatives.

Administer within three hours of reconstitution.
Discard unused contents.

GRIFOLS

Warning: This product is prepared from large
pools of human plasma. Human blood and its
components may transmit infectious agents. See
package insert, WARNINGS AND PRECAUTIONS.

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

Storage: Store between 2 and 8 °C. Avoid
freezing which might damage diluent bottle.
May be stored at room temperature not to exceed
30 °C for 1 month.

Single dose container for intravenous
administration only.

Date removed from refrigeration:

Grifols Biologicals LLC
5555 Valley Boulevard
Los Angeles, CA 90032, U.S.A.
U.S. License No 1694

GRIFOLS

GTIN 00368516361023
LOT XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXX XXXXXX
IU FI X/Vial XXXX

3063700

Principal Display Panel – 1000 IU Carton Label

NDC 68516-3611-2      1000 IU FIX Range

Coagulation Factor IX (Human)
AlphaNine® SD

Solvent Detergent Treated / Virus Filtered

Rx only
For Intravenous Administration          10 mL 

GRIFOLS

Contents:
One vial Coagulation Factor IX (Human), AlphaNine®
SD, one vial 10 mL Sterile Water for Injection, USP,
one Mix2Vial® filter transfer set, and directions for
use.

For intravenous administration.

The reconstituted product contains not more than
0.04 unit of heparin, and not more than 0.2 mg of
dextrose, and not more than 1.0 µg polysorbate 80
and 0.10 µg tri(n-butyl) phosphate per IU of Factor IX.

Contains no preservatives.

Administer within three hours of reconstitution.
Discard unused contents.

Warning: This product is prepared from large
pools of human plasma. Human blood and its
components may transmit infectious agents. See
package insert, WARNINGS AND PRECAUTIONS.

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

Storage: Store between 2 and 8 °C. Avoid
freezing which might damage diluent bottle.
May be stored at room temperature not to exceed
30 °C for 1 month.

Single dose container for intravenous
administration only.

Date removed from refrigeration:

Grifols Biologicals LLC
5555 Valley Boulevard
Los Angeles, CA 90032, U.S.A.
U.S. License No 1694

GRIFOLS

GTIN 00368516361122
LOT XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXX XXXXXX 
IU FI X/Vial XXXX

3063698

Principal Display Panel – 1500 IU Carton Label

NDC 68516-3612-2       1500 IU FIX Range

Coagulation Factor IX (Human)
AlphaNine® SD

Solvent Detergent Treated / Virus Filtered

Rx only
For Intravenous Administration           10 mL

GRIFOLS

Contents: 
One vial Coagulation Factor IX (Human), AlphaNine® 
SD,one vial 10 mL Sterile Water for Injection, USP,
one Mix2Vial® filter transfer set, and directions for
use.

For intravenous administration.

The reconstituted product contains not more than
0.04 unit of heparin, and not more than 0.2 mg of
dextrose, and not more than 1.0 µg polysorbate 80
and 0.10 µg tri(n-butyl) phosphate per IU of Factor IX.

Contains no preservatives.

Administer within three hours of reconstitution.
Discard unused contents.

GRIFOLS

Warning: This product is prepared from large
pools of human plasma. Human blood and its
components may transmit infectious agents. See
package insert, WARNINGS AND PRECAUTIONS.

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

Storage: Store between 2 and 8 °C. Avoid
freezing which might damage diluent bottle.
May be stored at room temperature not to exceed
30 °C for 1 month.

Single dose container for intravenous
administration only.

Date removed from refrigeration:

Grifols Biologicals LLC
5555 Valley Boulevard
Los Angeles, CA 90032, U.S.A.
U.S. License No 1694

GRIFOLS

GTIN 00368516361221
LOT XXXXXXXXXX
EXP DDMMMYYYY
SN XXXXXXXXXX XXXXXX
IU FI X/Vial XXXX

3063696

NDC 76297-002-12

Sterile Water for Injection, USP

10 mL
Rx Only

For reconstitution of accompanying product

Single-Dose Container, Nonpyrogenic

Do not use unless clear. No antimicrobial agent or other substance has been added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion.

Mfd by: Laboratorios Grifols, S. A. Parets del Vallès,
Barcelona 08150 Spain


Lot

EXP

3057423


NDC 68516-1002-2

Sterile Water for Injection, USP

10 mL

Rx Only

For reconstitution of accompanying product

Single-Dose Container, Nonpyrogenic

Do not use unless clear. No antimicrobial agent or other substance has been added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion.

Mfd by: Laboratorios Grifols, S. A. Parets del Vallès, Barcelona 08150 Spain
Mfd for: Grifols Biologicals LLC Los Angeles, CA 90032, USA

Lot

EXP

3051533