FDA.reportPublic FDA data

MAYZENT

Product NDC
0078-1014
11-digit product format
000781014
Labeler code
0078
Product ID
0078-1014_905dd6df-a774-4f5c-aa7a-f21c79944ed6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
siponimod
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA209884
Marketing category
NDA
Marketing start
2019-03-26
Substance
SIPONIMOD
Active strength
1 mg/1
Pharmacologic classes
Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MAYZENT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIPONIMOD1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRR6P8L282I
Rxcui2121090, 2121096, 2121098, 2121100, 2123313, 2123314, 2594606, 2594608, 2594796, 2594797

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
015bcce2-91d4-4c7b-b48c-ea536d3b44acProduct name120190701

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-1014-152023-08-01C16284748780-10191ceaa-6643-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019
0078-1014-932023-08-01C16284748780-10191ceaa-6643-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019
0078-1014-152023-07-28C16284748780-10191ceaa-6643-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019
0078-1014-932023-07-28C16284748780-10191ceaa-6643-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT. MAYZENT ® (siponimod) tablets, for oral use Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1014-15MAYZENT30 in 1 BOTTLETABLET, FILM COATED3016
0078-1014-93MAYZENT30 in 1 BOTTLETABLET, FILM COATED3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1014-15EA - Each0078-1014dfee3dd8-3e69-48b1-893b-302954b4dc4a12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1014MAYZENT (SIPONIMOD) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]14Current NDC, Legacy NDC, 2 package rows20240724_44492772-5aed-4627-bd85-e8e89f308bb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123314{12 (siponimod 0.25 MG Oral Tablet [Mayzent]) } Pack [Mayzent 2 MG Starter Pack]BPCK44492772-5aed-4627-bd85-e8e89f308bb316
2594797{7 (siponimod 0.25 MG Oral Tablet [Mayzent]) } Pack [Mayzent 1 MG Starter Pack]BPCK44492772-5aed-4627-bd85-e8e89f308bb316
2123313{12 (siponimod 0.25 MG Oral Tablet) } PackGPCK44492772-5aed-4627-bd85-e8e89f308bb316
2594796{7 (siponimod 0.25 MG Oral Tablet) } PackGPCK44492772-5aed-4627-bd85-e8e89f308bb316
2121096MAYZENT 0.25 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2594608MAYZENT 1 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2594797Mayzent 1 MG Starter PackPSN44492772-5aed-4627-bd85-e8e89f308bb316
2121100MAYZENT 2 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2123314Mayzent 2 MG Starter PackPSN44492772-5aed-4627-bd85-e8e89f308bb316
2123313siponimod 0.25 MG (12) Oral Tablet PackPSN44492772-5aed-4627-bd85-e8e89f308bb316
2594796siponimod 0.25 MG (7) Oral Tablet PackPSN44492772-5aed-4627-bd85-e8e89f308bb316
2121090siponimod 0.25 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2594606siponimod 1 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2121098siponimod 2 MG Oral TabletPSN44492772-5aed-4627-bd85-e8e89f308bb316
2121096siponimod 0.25 MG Oral Tablet [Mayzent]SBD44492772-5aed-4627-bd85-e8e89f308bb316
2594608siponimod 1 MG Oral Tablet [Mayzent]SBD44492772-5aed-4627-bd85-e8e89f308bb316
2121100siponimod 2 MG Oral Tablet [Mayzent]SBD44492772-5aed-4627-bd85-e8e89f308bb316
2121090siponimod 0.25 MG Oral TabletSCD44492772-5aed-4627-bd85-e8e89f308bb316
2594606siponimod 1 MG Oral TabletSCD44492772-5aed-4627-bd85-e8e89f308bb316
2121098siponimod 2 MG Oral TabletSCD44492772-5aed-4627-bd85-e8e89f308bb316
2121096Mayzent 0.25 MG Oral TabletSY44492772-5aed-4627-bd85-e8e89f308bb316
2594608Mayzent 1 MG Oral TabletSY44492772-5aed-4627-bd85-e8e89f308bb316
2594797Mayzent 1 MG Starter PackSY44492772-5aed-4627-bd85-e8e89f308bb316
2121100Mayzent 2 MG Oral TabletSY44492772-5aed-4627-bd85-e8e89f308bb316
2123314Mayzent 2 MG Starter PackSY44492772-5aed-4627-bd85-e8e89f308bb316
2594796siponimod 0.25 MG (7) Oral Tablet PackSY44492772-5aed-4627-bd85-e8e89f308bb316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-1014-150007810141530 TABLET, FILM COATED in 1 BOTTLE (0078-1014-15) 2022-03-010000-00-00NoNoCurrent
0078-1014-930007810149330 TABLET, FILM COATED in 1 BOTTLE (0078-1014-93) 2022-03-010000-00-00YesNoCurrent