ponvory

Generic: ponesimod

Labeler: janssen pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ponvory
Generic Name ponesimod
Labeler janssen pharmaceuticals, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ponesimod 20 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50458-720
Product ID 50458-720_339b28be-aa00-df1a-e063-6294a90a5453
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213498
Marketing Start 2021-03-18
Marketing End 2027-03-31

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 50458720
Hyphenated Format 50458-720

Supplemental Identifiers

RxCUI
2532305 2532311 2532314 2532316 2532318 2532320 2532322 2532324 2532327 2532329 2532331 2532333 2532335 2532337 2532339 2532341 2532343 2532345 2532347 2532349 2532350 2532351
UNII
5G7AKV2MKP
NUI
N0000181815 N0000181816

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 ponvory (source: ndc)
Generic Name ponesimod (source: ndc)
Application Number NDA213498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50458-720-30) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

50458-720-30 1 BOTTLE in 1 CARTON (50458-720-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

ponesimod (20 mg/1)

Linked Drug Pages (1)

PONVORY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "339b28be-aa00-df1a-e063-6294a90a5453", "openfda": {"nui": ["N0000181815", "N0000181816"], "unii": ["5G7AKV2MKP"], "rxcui": ["2532305", "2532311", "2532314", "2532316", "2532318", "2532320", "2532322", "2532324", "2532327", "2532329", "2532331", "2532333", "2532335", "2532337", "2532339", "2532341", "2532343", "2532345", "2532347", "2532349", "2532350", "2532351"], "spl_set_id": ["5be69660-738c-4db7-b0d4-517aa873dc41"], "pharm_class_epc": ["Sphingosine 1-phosphate Receptor Modulator [EPC]"], "pharm_class_moa": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50458-720-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50458-720-30", "marketing_end_date": "20270331", "marketing_start_date": "20210318"}], "brand_name": "PONVORY", "product_id": "50458-720_339b28be-aa00-df1a-e063-6294a90a5453", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "50458-720", "generic_name": "Ponesimod", "labeler_name": "Janssen Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PONVORY", "active_ingredients": [{"name": "PONESIMOD", "strength": "20 mg/1"}], "application_number": "NDA213498", "marketing_category": "NDA", "marketing_end_date": "20270331", "marketing_start_date": "20210318"}