COSENTYX

Product NDC
0078-1168
11-digit product format
000781168
Labeler code
0078
Product ID
0078-1168_ecc0059c-d566-4830-b4c1-35535c9ecca2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
secukinumab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
BLA761349
Marketing category
BLA
Marketing start
2023-10-06
Substance
SECUKINUMAB
Active strength
25 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

Related Records

Active Ingredients

IngredientStrength
SECUKINUMAB25 mg/mL

Harmonized Identifiers

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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
DLG4EML025SECUKINUMAB1229022-83-6SECUKINUMAB

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0078-1168-61000781168615 mL in 1 VIAL, GLASS (0078-1168-61) 5 ml2023-10-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
COSENTYXNovartis Pharmaceuticals Corporation2026-04-17HUMAN PRESCRIPTION DRUG LABEL29