NDC Code(s) : 66658-501-01, 66658-505-01, 66658-510-01, 66658-522-01, 66658-523-01, 66658-524-01, 66658-525-01
Packager : Swedish Orphan Biovitrum AB (publ)

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GAMIFANTemapalumab-lzsg INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66658-501
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emapalumab(UNII: 3S252O2Z4X)
(emapalumab - UNII:3S252O2Z4X) 		emapalumab10 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66658-501-011 in 1 CARTON 17/05/2019
12 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761107 05/17/2019
GAMIFANTemapalumab-lzsg INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66658-505
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emapalumab(UNII: 3S252O2Z4X)
(emapalumab - UNII:3S252O2Z4X) 		emapalumab50 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66658-505-011 in 1 CARTON 17/05/2019
110 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761107 05/17/2019
GAMIFANTemapalumab-lzsg INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66658-510
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emapalumab(UNII: 3S252O2Z4X)
(emapalumab - UNII:3S252O2Z4X) 		emapalumab100 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66658-510-011 in 1 CARTON 26/06/2020
120 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761107 06/26/2020
GAMIFANTemapalumab-lzsg INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66658-522
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emapalumab(UNII: 3S252O2Z4X)
(emapalumab - UNII:3S252O2Z4X) 		emapalumab50 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66658-522-011 in 1 CARTON 06/07/2023
12 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761107 06/07/2023
GAMIFANTemapalumab-lzsg INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66658-523
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emapalumab(UNII: 3S252O2Z4X)
(emapalumab - UNII:3S252O2Z4X) 		emapalumab100 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66658-523-011 in 1 CARTON 06/07/2023
14 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761107 06/07/2023
GAMIFANTemapalumab-lzsg INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66658-524
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emapalumab(UNII: 3S252O2Z4X)
(emapalumab - UNII:3S252O2Z4X) 		emapalumab250 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66658-524-011 in 1 CARTON 06/07/2023
110 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761107 06/07/2023
GAMIFANTemapalumab-lzsg INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66658-525
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emapalumab(UNII: 3S252O2Z4X)
(emapalumab - UNII:3S252O2Z4X) 		emapalumab500 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66658-525-011 in 1 CARTON 06/07/2023
120 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761107 06/07/2023

LABELER - Swedish Orphan Biovitrum AB (publ)(354010589)

Establishment
Name Address ID/FEI Business Operations
Patheon Italia S.p.A 434078638 MANUFACTURE(66658-501, 66658-505, 66658-510, 66658-522, 66658-523, 66658-524, 66658-525)

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 10mg/2mL Carton Label

NDC 66658-501-01

Gamifant ®
(emapalumab-lzsg)
Injection

10 mg/2 mL
(5 mg/mL)

For intravenous infusion only.

Requires dilution prior to administration.

Single-dose vial. Discard unused portion.

Rx only

Dispense the enclosed Medication Guide
to each patient.

Principal Display Panel - 10mg/2mL Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 50mg/10mL Carton Label

NDC 66658-505-01

Gamifant ®
(emapalumab-lzsg)
Injection

50 mg/10 mL
(5 mg/mL)

For intravenous infusion only.

Requires dilution prior to administration.

Single-dose vial. Discard unused portion.

Rx only

Dispense the enclosed Medication Guide
to each patient.

Principal Display Panel - 50mg/10mL Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 100mg/20mL Carton Label

NDC 66658-510-01

Gamifant ®
(emapalumab-lzsg)
Injection

100 mg/20 mL
(5 mg/mL)

For intravenous infusion only.

Requires dilution prior to administration.

Single-dose vial. Discard unused portion.

Rx only

Dispense the enclosed Medication Guide
to each patient.

Principal Display Panel - 100mg/20mL Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 50 mg/2 mL Carton Label

NDC 66658-522-01

Gamifant ®

(emapalumab-lzsg)
Injection

50 mg/2 mL
(25 mg/mL)

For intravenous infusion only.

Requires dilution prior to administration.

Single-dose vial. Discard unused portion.

Rx only

Dispense the enclosed Medication Guide
to each patient.

Principal Display Panel – 50 mg/2 mL Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 100 mg/4 mL Carton Label

NDC 66658-523-01

Gamifant ®

(emapalumab-lzsg)
Injection

100 mg/4 mL
(25 mg/mL)

For intravenous infusion only.

Requires dilution prior to administration.

Single-dose vial. Discard unused portion.

Rx only

Dispense the enclosed Medication Guide
to each patient.

Principal Display Panel – 100 mg/4 mL Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 250 mg/10 mL Carton Label

NDC 66658-524-01

Gamifant ®

(emapalumab-lzsg)
Injection

250 mg/10 mL
(25 mg/mL)

For intravenous infusion only.

Requires dilution prior to administration.

Single-dose vial. Discard unused portion.

Rx only

Dispense the enclosed Medication Guide
to each patient.

Principal Display Panel – 250 mg/10 mL Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 500 mg/20 mL Carton Label

NDC 66658-525-01

Gamifant ®

(emapalumab-lzsg)
Injection

500 mg/20 mL
(25 mg/mL)

For intravenous infusion only.

Requires dilution prior to administration.

Single-dose vial. Discard unused portion.

Rx only

Dispense the enclosed Medication Guide
to each patient.

Principal Display Panel – 500 mg/20 mL Carton Label