NDC Code 66658-523-01 - Emapalumab

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
emapalumab(UNII: 3S252O2Z4X) (emapalumab - UNII:3S252O2Z4X)	emapalumab	10 mg in 2 mL

Ingredient Name	Strength
Inactive Ingredients
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66658-501-01	1 in 1 CARTON	17/05/2019
1		2 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
emapalumab(UNII: 3S252O2Z4X) (emapalumab - UNII:3S252O2Z4X)	emapalumab	50 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66658-505-01	1 in 1 CARTON	17/05/2019
1		10 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
emapalumab(UNII: 3S252O2Z4X) (emapalumab - UNII:3S252O2Z4X)	emapalumab	100 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66658-510-01	1 in 1 CARTON	26/06/2020
1		20 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
emapalumab(UNII: 3S252O2Z4X) (emapalumab - UNII:3S252O2Z4X)	emapalumab	50 mg in 2 mL

Ingredient Name	Strength
Inactive Ingredients
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66658-522-01	1 in 1 CARTON	06/07/2023
1		2 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
emapalumab(UNII: 3S252O2Z4X) (emapalumab - UNII:3S252O2Z4X)	emapalumab	100 mg in 4 mL

Ingredient Name	Strength
Inactive Ingredients
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66658-523-01	1 in 1 CARTON	06/07/2023
1		4 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
emapalumab(UNII: 3S252O2Z4X) (emapalumab - UNII:3S252O2Z4X)	emapalumab	250 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66658-524-01	1 in 1 CARTON	06/07/2023
1		10 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
emapalumab(UNII: 3S252O2Z4X) (emapalumab - UNII:3S252O2Z4X)	emapalumab	500 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
histidine(UNII: 4QD397987E)
histidine monohydrochloride monohydrate(UNII: X573657P6P)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66658-525-01	1 in 1 CARTON	06/07/2023
1		20 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

NDC 66658-523-01
API & Excipient Details

Emapalumab marketed by Swedish Orphan Biovitrum AB (publ) under NDC Code 66658-523-01

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)

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 66658-523-01 API & Excipient Details

Emapalumab marketed by Swedish Orphan Biovitrum AB (publ) under NDC Code 66658-523-01

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

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 66658-523-01
API & Excipient Details

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)