mayzent

Generic: siponimod

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

Drug Facts

Product Profile

Brand Name mayzent
Generic Name siponimod
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

siponimod .25 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0979
Product ID 0078-0979_905dd6df-a774-4f5c-aa7a-f21c79944ed6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209884
Listing Expiration 2026-12-31
Marketing Start 2019-03-26

Pharmacologic Class

Established (EPC)
sphingosine 1-phosphate receptor modulator [epc]
Mechanism of Action
sphingosine 1-phosphate receptor modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780979
Hyphenated Format 0078-0979

Supplemental Identifiers

RxCUI
2121090 2121096 2121098 2121100 2123313 2123314 2594606 2594608 2594796 2594797
UNII
RR6P8L282I
NUI
N0000181816 N0000181815

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 mayzent (source: ndc)
Generic Name siponimod (source: ndc)
Application Number NDA209884 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 12 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-12)
  • 28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-50)
  • 7 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-89)
  • 28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-92)
source: ndc

Packages (4)

0078-0979-12 12 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-12) 0078-0979-50 28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-50) 0078-0979-89 7 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-89) 0078-0979-92 28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-92)

Ingredients (1)

siponimod (.25 mg/1)

Linked Drug Pages (1)

MAYZENT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "905dd6df-a774-4f5c-aa7a-f21c79944ed6", "openfda": {"nui": ["N0000181816", "N0000181815"], "unii": ["RR6P8L282I"], "rxcui": ["2121090", "2121096", "2121098", "2121100", "2123313", "2123314", "2594606", "2594608", "2594796", "2594797"], "spl_set_id": ["44492772-5aed-4627-bd85-e8e89f308bb3"], "pharm_class_epc": ["Sphingosine 1-phosphate Receptor Modulator [EPC]"], "pharm_class_moa": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-12)", "package_ndc": "0078-0979-12", "marketing_start_date": "20190326"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-50)", "package_ndc": "0078-0979-50", "marketing_start_date": "20190326"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-89)", "package_ndc": "0078-0979-89", "marketing_start_date": "20220301"}, {"sample": true, "description": "28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-92)", "package_ndc": "0078-0979-92", "marketing_start_date": "20190326"}], "brand_name": "MAYZENT", "product_id": "0078-0979_905dd6df-a774-4f5c-aa7a-f21c79944ed6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "0078-0979", "generic_name": "siponimod", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MAYZENT", "active_ingredients": [{"name": "SIPONIMOD", "strength": ".25 mg/1"}], "application_number": "NDA209884", "marketing_category": "NDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}