PROCRIT (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 2,000 Unit Vial Carton

2,000 Units/mL

NDC 59676-302- 01
6-1 mL Single-dose vials
Discard unused portion.

PROCRIT®
EPOETIN ALFA

2,000 Units/mL

For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative

Attention: A medication
guide is required for each patient.
For more copies see Procrit.com
or call 1-800-JANSSEN (1-800-526-7736)

Each 1 mL vial contains: 2,000 units of recombinant epoetin alfa and
2.5 mg Albumin (Human) in a sterile, buffered solution (pH 6.9 ± 0.3)
of sodium citrate (5.8 mg), sodium chloride (5.9 mg) and citric acid(0.06 mg) in Water for Injection, USP. No U.S. standard of potency.

Rx only

Principal Display Panel -- 2,000 Unit Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3,000 Unit Vial Carton

3,000 Units/mL

NDC 59676-303- 01
6-1 mL Single-dose vials
Discard unused portion.

PROCRIT®
EPOETIN ALFA

3,000 Units/mL

For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative

Attention: A medication
guide is required for each patient.
For more copies see Procrit.com
or call 1-800-JANSSEN (1-800-526-7736)

Each 1 mL vial contains: 3,000 units of recombinant epoetin alfa and
2.5 mg Albumin (Human) in a sterile, buffered solution (pH 6.9 ± 0.3)
of sodium citrate (5.8 mg), sodium chloride (5.9 mg) and citric acid(0.06 mg) in Water for Injection, USP. No U.S. standard of potency.

Rx only

Principal Display Panel -- 3,000 Unit Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4,000 Unit Vial Carton

4,000 Units/mL

NDC 59676-304- 01
6-1 mL Single-dose vials
Discard unused portion.

PROCRIT®
EPOETIN ALFA

4,000 Units/mL

For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative

Attention: A medication
guide is required for each patient.
For more copies see Procrit.com
or call 1-800-JANSSEN (1-800-526-7736)

Each 1 mL vial contains: 4,000 units of recombinant epoetin alfa and
2.5 mg Albumin (Human) in a sterile, buffered solution (pH 6.9 ± 0.3)
of sodium citrate (5.8 mg), sodium chloride (5.9 mg) and citric acid(0.06 mg) in Water for Injection, USP. No U.S. standard of potency.

Rx only

Principal Display Panel -- 4,000 Unit Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10,000 Unit Vial Carton

10,000 Units/mL

NDC 59676-310- 01
6-1 mL Single-dose vials
Discard unused portion.

PROCRIT®
EPOETIN ALFA

10,000 Units/mL

For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative

Attention: A medication
guide is required for each patient.
For more copies see Procrit.com
or call 1-800-JANSSEN (1-800-526-7736)

Each 1 mL vial contains: 10,000 units of recombinant epoetin alfa and
2.5 mg Albumin (Human) in a sterile, buffered solution (pH 6.9 ± 0.3)
of sodium citrate (5.8 mg), sodium chloride (5.9 mg) and citric acid(0.06 mg) in Water for Injection, USP. No U.S. standard of potency.

Rx only

Principal Display Panel -- 10,000 Unit Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40,000 Unit Vial Carton

40,000 Units/mL

NDC 59676-340- 01
4-1 mL Single-dose vials
Discard unused portion.

PROCRIT®
EPOETIN ALFA

40,000 Units/mL

For Intravenous or Subcutaneous Use Only
Sterile Solution — No Preservative

Attention: A medication
guide is required for each patient.
For more copies see Procrit.com
or call 1-800-JANSSEN
(1-800-526-7736)

Each 1 mL vial contains: 40,000 units of recombinant
epoetin alfa and 2.5 mg Albumin (Human) in a sterile,
buffered solution (pH 6.9 ± 0.3) of sodium phosphate
monobasic monohydrate (1.2 mg), sodium phosphate
dibasic anhydrate (1.8 mg), sodium citrate (0.7 mg),
sodium chloride (5.8 mg), and citric acid (6.8 mcg) inWater for Injection, USP. No U.S. standard of potency.

Rx only

Principal Display Panel -- 40,000 Unit Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20,000 Units/2 mL Vial Carton

20,000 Units/2 mL (10,000 Units/mL)

NDC 59676-312-04
4-2 mL Multiple-dose Vials

PROCRIT®
EPOETIN ALFA

20,000 Units/2 mL (10,000 Units/mL)

Multiple-dose Vials

Sterile solution — Preserved. 10,000 Units/mL
For Intravenous or Subcutaneous Use Only.

Attention:
A medication guide is
required for each
patient. For more
copies see Procrit.com
or call 1-800-JANSSEN (1-800-526-7736)

2 mL

Rx only

Principal Display Panel -- 20,000 Units/2 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20,000 Unit Vial Carton

20,000 Units/mL

NDC 59676-320-04
4-1 mL Multiple-dose Vials

PROCRIT®
EPOETIN ALFA

20,000 Units/mL

Multiple-dose Vials

Sterile solution — Preserved. 20,000 Units/mL
For Intravenous or Subcutaneous Use Only

Attention:
A medication guide is required
for each patient. For more copies
see Procrit.com or call 1-800-JANSSEN (1-800-526-7736)

1 mL

Rx only

Principal Display Panel -- 20,000 Unit Vial Carton
(click image for full-size original)
PROCRIT erythropoietin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-302
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythropoietin (Erythropoietin) Erythropoietin 2000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
albumin human 2.5 mg in 1 mL
sodium citrate, unspecified form 5.8 mg in 1 mL
sodium chloride 5.8 mg in 1 mL
citric acid monohydrate 0.06 mg in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-302-01 6 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (59676-302-00)
1 NDC:59676-302-00 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (59676-302-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103234 06/01/1989
PROCRIT erythropoietin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-303
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythropoietin (Erythropoietin) Erythropoietin 3000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
albumin human 2.5 mg in 1 mL
sodium citrate, unspecified form 5.8 mg in 1 mL
sodium chloride 5.8 mg in 1 mL
citric acid monohydrate 0.06 mg in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-303-01 6 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (59676-303-00)
1 NDC:59676-303-00 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (59676-303-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103234 06/01/1989
PROCRIT erythropoietin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-304
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythropoietin (Erythropoietin) Erythropoietin 4000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
albumin human 2.5 mg in 1 mL
sodium citrate, unspecified form 5.8 mg in 1 mL
sodium chloride 5.8 mg in 1 mL
citric acid monohydrate 0.06 mg in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-304-01 6 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (59676-304-00)
1 NDC:59676-304-00 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (59676-304-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103234 06/01/1989
PROCRIT erythropoietin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-310
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythropoietin (Erythropoietin) Erythropoietin 10000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
albumin human 2.5 mg in 1 mL
sodium citrate, unspecified form 5.8 mg in 1 mL
sodium chloride 5.8 mg in 1 mL
citric acid monohydrate 0.06 mg in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-310-01 6 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (59676-310-00)
1 NDC:59676-310-00 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (59676-310-01)
2 NDC:59676-310-02 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (59676-310-00)
2 NDC:59676-310-00 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (59676-310-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103234 06/01/1989
PROCRIT erythropoietin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-340
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythropoietin (Erythropoietin) Erythropoietin 40000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
albumin human 2.5 mg in 1 mL
sodium phosphate, monobasic, monohydrate 1.2 mg in 1 mL
sodium phosphate, dibasic, anhydrous 1.8 mg in 1 mL
sodium citrate, unspecified form 0.7 mg in 1 mL
sodium chloride 5.8 mg in 1 mL
citric acid monohydrate 6.8 ug in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-340-01 4 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (59676-340-00)
1 NDC:59676-340-00 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (59676-340-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103234 06/01/1989
PROCRIT erythropoietin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-312
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythropoietin (Erythropoietin) Erythropoietin 10000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
albumin human 2.5 mg in 1 mL
sodium citrate, unspecified form 1.3 mg in 1 mL
sodium chloride 8.2 mg in 1 mL
citric acid monohydrate 0.11 mg in 1 mL
benzyl alcohol
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-312-04 4 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (59676-312-00)
1 NDC:59676-312-00 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (59676-312-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103234 06/01/1989
PROCRIT erythropoietin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59676-320
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Erythropoietin (Erythropoietin) Erythropoietin 20000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
albumin human 2.5 mg in 1 mL
sodium citrate, unspecified form 5.8 mg in 1 mL
sodium chloride 5.8 mg in 1 mL
citric acid monohydrate 0.06 mg in 1 mL
benzyl alcohol
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59676-320-04 4 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (59676-320-00)
1 NDC:59676-320-00 1 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (59676-320-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103234 06/01/1989
Labeler — Janssen Products, LP (804684207)
Establishment
Name Address ID/FEI Operations
Amgen Manufacturing Ltd 785800020 MANUFACTURE (59676-302), MANUFACTURE (59676-303), MANUFACTURE (59676-304), MANUFACTURE (59676-310), MANUFACTURE (59676-340), MANUFACTURE (59676-312), MANUFACTURE (59676-320), ANALYSIS (59676-302), ANALYSIS (59676-303), ANALYSIS (59676-304), ANALYSIS (59676-310), ANALYSIS (59676-340), ANALYSIS (59676-312), ANALYSIS (59676-320)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 ANALYSIS (59676-302), ANALYSIS (59676-303), ANALYSIS (59676-304), ANALYSIS (59676-310), ANALYSIS (59676-340), ANALYSIS (59676-312), ANALYSIS (59676-320), MANUFACTURE (59676-302), MANUFACTURE (59676-303), MANUFACTURE (59676-304), MANUFACTURE (59676-310), MANUFACTURE (59676-340), MANUFACTURE (59676-312), MANUFACTURE (59676-320)
Establishment
Name Address ID/FEI Operations
Amgen, Inc. 039976196 MANUFACTURE (59676-302), MANUFACTURE (59676-303), MANUFACTURE (59676-304), MANUFACTURE (59676-310), MANUFACTURE (59676-340), MANUFACTURE (59676-312), MANUFACTURE (59676-320), ANALYSIS (59676-302), ANALYSIS (59676-303), ANALYSIS (59676-304), ANALYSIS (59676-310), ANALYSIS (59676-340), ANALYSIS (59676-312), ANALYSIS (59676-320)

Revised: 05/2020 Janssen Products, LP

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