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United States · US · US:0078-0986_905dd6df-a774-4f5c-aa7a-f21c79944ed6
MAYZENT
Orange BookUNIISPLATC L04AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL04AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11007809861530 TABLET, FILM COATED in 1 BOTTLE (0078-0986-15)
- ndc11007809864515 TABLET, FILM COATED in 1 BOTTLE (0078-0986-45)
- ndc11007809869330 TABLET, FILM COATED in 1 BOTTLE (0078-0986-93)
- ndc11007809869415 TABLET, FILM COATED in 1 BOTTLE (0078-0986-94)
Annotations
UNII (FDA Substance ID)
RR6P8L282I
SIPONIMOD
RxCUI 2121085
Orange Book
N209884
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RR6P8L282I",
"rxcui": "2121085",
"inchikey": "KIHYPELVXPAIDH-HNSNBQBZSA-N",
"display_name": "SIPONIMOD",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"44492772-5aed-4627-bd85-e8e89f308bb3": {
"match": "brand_token",
"title": "MAYZENT (SIPONIMOD) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "16",
"published_date": "2025-09-01"
}
},
"productid": "0078-0986_905dd6df-a774-4f5c-aa7a-f21c79944ed6",
"productndc": "0078-0986",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209884",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.25MG BASE",
"product_no": "001",
"approval_date": "Mar 26, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Mar 26, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE",
"product_no": "003",
"approval_date": "Aug 24, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SIPONIMOD",
"proprietary_name": "MAYZENT",
"active_ingred_unit": "mg/1",
"application_number": "NDA209884",
"marketing_category": "NDA",
"nonproprietary_name": "siponimod",
"start_marketing_date": "20190326",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L04AE03.
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