NDC Code 0078-1070-96 - Secukinumab

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

COSENTYXsecukinumab INJECTION

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SECUKINUMAB(UNII: DLG4EML025) (SECUKINUMAB - UNII:DLG4EML025)	SECUKINUMAB	150 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HISTIDINE(UNII: 4QD397987E)	3.103 mg in 1 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)	3.103 mg in 1 mL
METHIONINE(UNII: AE28F7PNPL)	0.746 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)	0.200 mg in 1 mL
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)	75.67 mg in 1 mL
NITROGEN(UNII: N762921K75)
WATER(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0078-0639-41	2 mL in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)	21/01/2015
2	NDC:0078-0639-68	1 mL in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)	21/01/2015
3	NDC:0078-0639-98	2 mL in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)	21/01/2015
4	NDC:0078-0639-97	1 mL in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)	21/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125504	01/21/2015

COSENTYXsecukinumab INJECTION

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SECUKINUMAB(UNII: DLG4EML025) (SECUKINUMAB - UNII:DLG4EML025)	SECUKINUMAB	75 mg in 0.5 mL

Ingredient Name	Strength
Inactive Ingredients
HISTIDINE(UNII: 4QD397987E)	1.552 mg in 0.5 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)	1.552 mg in 0.5 mL
METHIONINE(UNII: AE28F7PNPL)	0.373 mg in 0.5 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)	0.10 mg in 0.5 mL
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)	37.83 mg in 0.5 mL
NITROGEN(UNII: N762921K75)
WATER(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0078-1056-97	1 in 1 CARTON	28/05/2021
1		0.5 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2	NDC:0078-1056-99	1 in 1 CARTON	28/05/2021
2		0.5 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125504	01/21/2015

COSENTYXsecukinumab INJECTION

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SECUKINUMAB(UNII: DLG4EML025) (SECUKINUMAB - UNII:DLG4EML025)	SECUKINUMAB	300 mg in 2 mL

Ingredient Name	Strength
Inactive Ingredients
HISTIDINE(UNII: 4QD397987E)	6.206 mg in 2 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)	6.206 mg in 2 mL
METHIONINE(UNII: AE28F7PNPL)	1.492 mg in 2 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)	0.40 mg in 2 mL
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)	151.34 mg in 2 mL
NITROGEN(UNII: N762921K75)
WATER(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0078-1070-68	1 in 1 CARTON	05/11/2023
1		2 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2	NDC:0078-1070-96	1 in 1 CARTON	05/11/2023
2		2 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125504	01/21/2015

COSENTYXsecukinumab INJECTION, SOLUTION, CONCENTRATE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SECUKINUMAB(UNII: DLG4EML025) (SECUKINUMAB - UNII:DLG4EML025)	SECUKINUMAB	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HISTIDINE(UNII: 4QD397987E)	5.67 mg in 1 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)	13.3 mg in 1 mL
METHIONINE(UNII: AE28F7PNPL)	3.73 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)	1.00 mg in 1 mL
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)	426 mg in 1 mL
NITROGEN(UNII: N762921K75)
WATER(UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0078-1168-61	5 mL in 1 VIAL, GLASS Type 0: Not a Combination Product	10/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA761349	10/06/2023

LABELER - Novartis Pharmaceuticals Corporation(002147023)

NDC 0078-1070-96
API & Excipient Details