FDA.reportPublic FDA data

COSENTYX

Product NDC
0078-0639
11-digit product format
000780639
Labeler code
0078
Product ID
0078-0639_ecc0059c-d566-4830-b4c1-35535c9ecca2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
secukinumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
BLA125504
Marketing category
BLA
Marketing start
2015-01-21
Substance
SECUKINUMAB
Active strength
150 mg/mL
Pharmacologic classes
Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COSENTYX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SECUKINUMAB150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DLG4EML025Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1599792Internal RxNorm lookup
1599797Internal RxNorm lookup
1653241Internal RxNorm lookup
1653243Internal RxNorm lookup
2550712Internal RxNorm lookup
2550713Internal RxNorm lookup
2637347Internal RxNorm lookup
2637348Internal RxNorm lookup
2667419Internal RxNorm lookup
2667423Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77c4b13e-7df3-42d4-81db-3d0cddb7f67aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27e332fb-2926-4a3d-abaa-4cdc3ec3b214Product name320250627
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0639-41COSENTYX2 mL in 1 CARTONINJECTION229
0078-0639-68COSENTYX1 mL in 1 CARTONINJECTION129
0078-0639-97COSENTYX1 mL in 1 CARTONINJECTION129
0078-0639-98COSENTYX2 mL in 1 CARTONINJECTION229

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0639-41ML - Milliliter0078-0639dd282c4e-4f3b-484b-a40f-0e3f4222db9512015-03-03
0078-0639-68ML - Milliliter0078-0639e6ed1404-186d-4838-8117-b7094a57f85012015-03-03
0078-0639-97ML - Milliliter0078-0639dc3e90f1-8a23-449a-ba3a-c9e3b8b9429612015-03-03
0078-0639-98ML - Milliliter0078-0639b1c7c2c8-108e-47af-8c7f-80b9ae37b3b812015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SECUKINUMABACTIVE INGREDIENTDLG4EML025COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]1
SECUKINUMABACTIVE MOIETYDLG4EML025COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]1
HISTIDINEINACTIVE INGREDIENT4QD397987ECOSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]1
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEINACTIVE INGREDIENTX573657P6PCOSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]1
METHIONINEINACTIVE INGREDIENTAE28F7PNPLCOSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]1
TREHALOSE DIHYDRATEINACTIVE INGREDIENT7YIN7J07X4COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RCOSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0639COSENTYX (SECUKINUMAB) INJECTION COSENTYX (SECUKINUMAB) INJECTION, SOLUTION, CONCENTRATE [NOVARTIS PHARMACEUTICALS CORPORATION]24Current NDC, Legacy NDC, 4 package rows20241013_77c4b13e-7df3-42d4-81db-3d0cddb7f67a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COSENTYXSECUKINUMABNovartis Pharmaceuticals Corporation77c4b13e-7df3-42d4-81db-3d0cddb7f67a2026-04-17Warnings, Adverse reactionsExact identifier
application number: BLA125504
ndc (product): 0078-0639

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125504Cosentyxsecukinumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667423Cosentyx 125 MG in 5 ML InjectionPSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
1653243Cosentyx 150 MG in 1 ML Auto-InjectorPSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
1599797Cosentyx 150 MG in 1 ML Prefilled SyringePSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2637348Cosentyx 300 MG in 2 ML Auto-InjectorPSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2550713Cosentyx 75 MG in 0.5 ML Prefilled SyringePSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2667419secukinumab 125 MG in 5 ML InjectionPSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
1653241secukinumab 150 MG in 1 ML Auto-InjectorPSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
1599792secukinumab 150 MG in 1 ML Prefilled SyringePSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2637347secukinumab 300 MG in 2 ML Auto-InjectorPSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2550712secukinumab 75 MG in 0.5 ML Prefilled SyringePSN77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
25507130.5 ML secukinumab 150 MG/ML Prefilled Syringe [Cosentyx]SBD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
16532431 ML secukinumab 150 MG/ML Auto-Injector [Cosentyx]SBD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
15997971 ML secukinumab 150 MG/ML Prefilled Syringe [Cosentyx]SBD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
26373482 ML secukinumab 150 MG/ML Auto-Injector [Cosentyx]SBD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
26674235 ML secukinumab 25 MG/ML Injection [Cosentyx]SBD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
25507120.5 ML secukinumab 150 MG/ML Prefilled SyringeSCD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
16532411 ML secukinumab 150 MG/ML Auto-InjectorSCD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
15997921 ML secukinumab 150 MG/ML Prefilled SyringeSCD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
26373472 ML secukinumab 150 MG/ML Auto-InjectorSCD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
26674195 ML secukinumab 25 MG/ML InjectionSCD77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
25507130.5 ML Cosentyx 150 MG/ML Prefilled SyringeSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
16532431 ML Cosentyx 150 MG/ML Auto-InjectorSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
15997971 ML Cosentyx 150 MG/ML Prefilled SyringeSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
26373482 ML Cosentyx 150 MG/ML Auto-InjectorSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
26674235 ML Cosentyx 25 MG/ML InjectionSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2667423Cosentyx 125 MG per 5 ML InjectionSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
1653243Cosentyx 150 MG per 1 ML Auto-InjectorSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
1599797Cosentyx 150 MG/ML 1ML Prefilled SyringeSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2637348Cosentyx 300 MG per 2 ML Auto-InjectorSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2550713Cosentyx 75 MG per 0.5 ML Prefilled SyringeSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2667419secukinumab 125 MG per 5 ML InjectionSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
1653241secukinumab 150 MG per 1 ML Auto-InjectorSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
1599792secukinumab 150 MG/ML 1ML Prefilled SyringeSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2637347secukinumab 300 MG per 2 ML Auto-InjectorSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29
2550712secukinumab 75 MG per 0.5 ML Prefilled SyringeSY77c4b13e-7df3-42d4-81db-3d0cddb7f67a29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0639-41000780639412 mL in 1 CARTON (0078-0639-41) 2 ml2015-01-210000-00-00NoNoCurrent
0078-0639-68000780639681 mL in 1 CARTON (0078-0639-68) 1 ml2015-01-210000-00-00NoNoCurrent
0078-0639-97000780639971 mL in 1 CARTON (0078-0639-97) 1 ml2015-01-210000-00-00NoNoCurrent
0078-0639-98000780639982 mL in 1 CARTON (0078-0639-98) 2 ml2015-01-210000-00-00NoNoCurrent