cosentyx

Generic: secukinumab

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name cosentyx
Generic Name secukinumab
Labeler novartis pharmaceuticals corporation
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

secukinumab 75 mg/.5mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1056
Product ID 0078-1056_718a8cb1-190e-4ec3-8e09-d614c9098348
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125504
Listing Expiration 2026-12-31
Marketing Start 2015-01-21

Pharmacologic Class

Established (EPC)
interleukin-17a antagonist [epc]
Mechanism of Action
interleukin-17a antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781056
Hyphenated Format 0078-1056

Supplemental Identifiers

RxCUI
1599792 1599797 1653241 1653243 2550712 2550713 2637347 2637348 2667419 2667423
UNII
DLG4EML025
NUI
N0000191495 N0000191494

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cosentyx (source: ndc)
Generic Name secukinumab (source: ndc)
Application Number BLA125504 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 75 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (0078-1056-97) / .5 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (0078-1056-99) / .5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

0078-1056-97 1 SYRINGE, GLASS in 1 CARTON (0078-1056-97) / .5 mL in 1 SYRINGE, GLASS 0078-1056-99 1 SYRINGE, GLASS in 1 CARTON (0078-1056-99) / .5 mL in 1 SYRINGE, GLASS

Ingredients (1)

secukinumab (75 mg/.5mL)

Linked Drug Pages (1)

COSENTYX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "718a8cb1-190e-4ec3-8e09-d614c9098348", "openfda": {"nui": ["N0000191495", "N0000191494"], "unii": ["DLG4EML025"], "rxcui": ["1599792", "1599797", "1653241", "1653243", "2550712", "2550713", "2637347", "2637348", "2667419", "2667423"], "spl_set_id": ["77c4b13e-7df3-42d4-81db-3d0cddb7f67a"], "pharm_class_epc": ["Interleukin-17A Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-17A Antagonists [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (0078-1056-97)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "0078-1056-97", "marketing_start_date": "20210528"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (0078-1056-99)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "0078-1056-99", "marketing_start_date": "20210528"}], "brand_name": "COSENTYX", "product_id": "0078-1056_718a8cb1-190e-4ec3-8e09-d614c9098348", "dosage_form": "INJECTION", "pharm_class": ["Interleukin-17A Antagonist [EPC]", "Interleukin-17A Antagonists [MoA]"], "product_ndc": "0078-1056", "generic_name": "secukinumab", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COSENTYX", "active_ingredients": [{"name": "SECUKINUMAB", "strength": "75 mg/.5mL"}], "application_number": "BLA125504", "marketing_category": "BLA", "marketing_start_date": "20150121", "listing_expiration_date": "20261231"}