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 Identifiers#

Field, Values table
FieldValues
UniiDLG4EML025
Rxcui1599792, 1599797, 1653241, 1653243, 2550712, 2550713, 2637347, 2637348, 2667419, 2667423

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

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