NDC 0078-0639

COSENTYX

Secukinumab

COSENTYX is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Secukinumab.

Product ID0078-0639_1b52f8f5-c6db-4d83-ac31-f566d2bf99a4
NDC0078-0639
Product TypeHuman Prescription Drug
Proprietary NameCOSENTYX
Generic NameSecukinumab
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-01-21
Marketing CategoryBLA / BLA
Application NumberBLA125504
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameSECUKINUMAB
Active Ingredient Strength150 mg/mL
Pharm ClassesInterleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-0639-41

2 mL in 1 CARTON (0078-0639-41)
Marketing Start Date2015-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0639-97 [00078063997]

COSENTYX INJECTION
Marketing CategoryBLA
Application NumberBLA125504
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-21

NDC 0078-0639-68 [00078063968]

COSENTYX INJECTION
Marketing CategoryBLA
Application NumberBLA125504
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-21

NDC 0078-0639-98 [00078063998]

COSENTYX INJECTION
Marketing CategoryBLA
Application NumberBLA125504
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-21

NDC 0078-0639-41 [00078063941]

COSENTYX INJECTION
Marketing CategoryBLA
Application NumberBLA125504
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-21

Drug Details

Active Ingredients

IngredientStrength
SECUKINUMAB150 mg/mL

OpenFDA Data

SPL SET ID:77c4b13e-7df3-42d4-81db-3d0cddb7f67a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1599792
  • 1599797
  • 1653243
  • 1653241
  • Pharmacological Class

    • Interleukin-17A Antagonist [EPC]
    • Interleukin-17A Antagonists [MoA]

    NDC Crossover Matching brand name "COSENTYX" or generic name "Secukinumab"

    NDCBrand NameGeneric Name
    0078-0639COSENTYXsecukinumab
    0078-1056COSENTYXsecukinumab

    Trademark Results [COSENTYX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COSENTYX
    COSENTYX
    86734365 4979935 Live/Registered
    Novartis AG
    2015-08-24
    COSENTYX
    COSENTYX
    85804029 4716891 Live/Registered
    Novartis AG
    2012-12-17

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