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 KIT
Manufacturer
Janssen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50458-707
Product ID 50458-707_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 50458707
Hyphenated Format 50458-707

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: label

Resolved Composition

Strengths
  • 2 mg
  • 3 mg
  • 4 mg
  • 5 mg
  • 6 mg
  • 7 mg
  • 8 mg
  • 9 mg
  • 10 mg
  • 20 mg
source: label
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied PONVORY ® (ponesimod) tablet is available as round, biconvex, film-coated tablets supplied in the following dosage strengths and package configurations. Starter Pack Tablet Strength Tablet Color Tablet Size Tablet Debossing Pack Size NDC Code 2 mg White 5.0 mm "2" on one side and an arch on the other side. Child Resistant Starter Pack (14 tablets) NDC 50458-707-14 3 mg Red 5.0 mm "3" on one side and an arch on the other side. 4 mg Purple 5.0 mm "4" on one side and an arch on the other side. 5 mg Green 8.6 mm "5" on one side and an arch and an "A" on the other side. 6 mg White 8.6 mm " 6 " on one side and an arch and an "A" on the other side. 7 mg Red 8.6 mm "7" on one side and an arch and an "A" on the other side. 8 mg Purple 8.6 mm "8" on one side and an arch and an "A" on the other side. 9 mg Brown 8.6 mm " 9 " on one side and an arch and an "A" on the other side. 10 mg Orange 8.6 mm "10" on one side and an arch and an "A" on the other side. Maintenance Dose Bottle Tablet Strength Tablet Color Tablet Size Tablet Debossing Pack Size NDC Code 20 mg Yellow 8.6 mm "20" on one side and an arch and an "A" on the other side. Bottle of 30 tablets with child-resistant closure. Each bottle contains a desiccant sachet. NDC 50458-720-30 16.2 Storage and Handling Starter Pack Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature] . Store in the original package. Maintenance Dose Bottle Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature] . Store in the original package. Do not discard desiccant. Protect from moisture. Keep out of reach of children.
  • PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton NDC 50458-720-30 Ponvory ® (ponesimod) tablets 20 mg ATTENTION: Dispense the enclosed Medication Guide to each patient. Rx only 30 film-coated tablets janssen PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - Kit Carton NDC 50458-707-14 Ponvory ® (ponesimod) tablets 14-day Starter Pack This 14-day Starter Pack Contains: two 2 mg, two 3 mg, two 4 mg, one 5 mg, one 6 mg, one 7 mg, one 8 mg, one 9 mg, and three 10 mg tablets ATTENTION: Dispense the enclosed Medication Guide to each patient. Rx only 14 film-coated tablets janssen PRINCIPAL DISPLAY PANEL - Kit Carton
source: label

Packages (0)

No package records.

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

PONVORY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": [], "brand_name": "PONVORY", "product_id": "50458-707_339b28be-aa00-df1a-e063-6294a90a5453", "dosage_form": "KIT", "product_ndc": "50458-707", "generic_name": "Ponesimod", "labeler_name": "Janssen Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PONVORY", "application_number": "NDA213498", "marketing_category": "NDA", "marketing_end_date": "20270331", "marketing_start_date": "20210318"}