NDC Code(s) : 0078-0639-41, 0078-0639-68, 0078-0639-98, 0078-0639-97, 0078-1056-97, 0078-1056-99, 0078-1070-68, 0078-1070-96, 0078-1168-61
Packager : Novartis Pharmaceuticals Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

COSENTYXsecukinumab INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0639
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SECUKINUMAB(UNII: DLG4EML025)
(SECUKINUMAB - UNII:DLG4EML025) 		SECUKINUMAB150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-0639-412 mL in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)21/01/2015
2NDC:0078-0639-681 mL in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)21/01/2015
3NDC:0078-0639-982 mL in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)21/01/2015
4NDC:0078-0639-971 mL in 1 CARTON Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)21/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125504 01/21/2015
COSENTYXsecukinumab INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-1056
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SECUKINUMAB(UNII: DLG4EML025)
(SECUKINUMAB - UNII:DLG4EML025) 		SECUKINUMAB75 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-1056-971 in 1 CARTON 28/05/2021
10.5 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0078-1056-991 in 1 CARTON 28/05/2021
20.5 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125504 01/21/2015
COSENTYXsecukinumab INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-1070
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SECUKINUMAB(UNII: DLG4EML025)
(SECUKINUMAB - UNII:DLG4EML025) 		SECUKINUMAB300 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-1070-681 in 1 CARTON 05/11/2023
12 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0078-1070-961 in 1 CARTON 05/11/2023
22 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125504 01/21/2015
COSENTYXsecukinumab INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-1168
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SECUKINUMAB(UNII: DLG4EML025)
(SECUKINUMAB - UNII:DLG4EML025) 		SECUKINUMAB25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-1168-615 mL in 1 VIAL, GLASS Type 0: Not a Combination Product10/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761349 10/06/2023

LABELER - Novartis Pharmaceuticals Corporation(002147023)

PRINCIPAL DISPLAY PANEL

NDC 0078-0639-97

Rx only

Cosentyx®

(secukinumab)

Injection

Single-dose Prefilled Syringe

150 mg/mL

1 Prefilled Syringe

ATTENTION: Dispense with enclosed Medication Guide.

For Subcutaneous Use Only

Sterile Solution - Contains No Preservative

Caution: Contains Natural Rubber Latex Which May Cause Allergic Reaction.

NOVARTIS

PRINCIPAL DISPLAY PANEL NDC 0078-0639-97 Rx only Cosentyx® (secukinumab) Injection Single-dose Prefilled Syringe 150 mg/mL 1 Prefilled Syringe ATTENTION: Dispense with enclosed Medication Guide. For Subcutaneous Use Only Sterile Solution - Contains No Preservative Caution: Contains Natural Rubber Latex Which May Cause Allergic Reaction. NOVARTIS

PRINCIPAL DISPLAY PANEL

NDC 0078-1056-97

Rx only

Cosentyx®

(secukinumab)
Injection

75 mg/0.5 mL

1 Single-dose Prefilled Syringe

For Subcutaneous Use Only

Caution: Contains Natural Rubber Latex
Which May Cause Allergic Reaction.

ATTENTION:
Dispense with enclosed Medication Guide.

NOVARTIS

PRINCIPAL DISPLAY PANEL NDC 0078-1056-97 Cosentyx® (secukinumab) Injection 75 mg/0.5 mL 1 Single-dose Prefilled Syringe For Subcutaneous Use Only Caution: Contains Natural Rubber Latex Which May Cause Allergic Reaction. ATTENTION: Dispense with enclosed Medication Guide. NOVARTIS

PRINCIPAL DISPLAY PANEL

NDC 0078-1070-68

Rx only

Cosentyx®

(secukinumab)
Injection

Single-dose prefilled UnoReady® Pen

300 mg/2 mL

For Subcutaneous Use Only

1 UnoReady® Pen

ATTENTION: Dispense with enclosed Medication Guide.

Carton contains: • 1 Single-dose prefilled UnoReady® Pen • Prescribing Information • Medication Guide • Instructions for Use

NOVARTIS

PRINCIPAL DISPLAY PANEL NDC 0078-1070-68 Rx only Cosentyx® (secukinumab) Injection Single-dose prefilled UnoReady® Pen 300 mg/2 mL For Subcutaneous Use Only 1 UnoReady® Pen ATTENTION: Dispense with enclosed Medication Guide. Carton contains: • 1 Single-dose prefilled UnoReady® Pen • Prescribing Information • Medication Guide • Instructions for Use NOVARTIS

PRINCIPAL DISPLAY PANEL

NDC 0078-1168-61

Rx only

Cosentyx®

(secukinumab)
Injection

125 mg/5 mL
(25 mg/mL)

For Intravenous Infusion After Dilution.

ATTENTION: Dispense with enclosed Medication Guide.

1 Single-Dose Vial.

Discard Unused Portion.

NOVARTIS

PRINCIPAL DISPLAY PANEL NDC 0078-1168-61 Rx only Cosentyx® (secukinumab) Injection 125 mg/5 mL (25 mg/mL) For Intravenous Infusion After Dilution. 1 Single-Dose Vial. Discard Unused Portion. NOVARTIS