ponvory

Generic: ponesimod

Labeler: vanda pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ponvory
Generic Name ponesimod
Labeler vanda pharmaceuticals inc.
Dosage Form KIT
Manufacturer
Vanda Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 43068-610
Product ID 43068-610_5280b437-62d4-417f-bd65-eb8944a85166
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213498
Listing Expiration 2026-12-31
Marketing Start 2021-03-18

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 43068610
Hyphenated Format 43068-610

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
UPC
0343068620019
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
  • 1 KIT in 1 CARTON (43068-610-09) * 1 BLISTER PACK in 1 CARTON (43068-606-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-609-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-608-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-607-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-611-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-605-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-604-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-603-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-602-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

43068-610-09 1 KIT in 1 CARTON (43068-610-09) * 1 BLISTER PACK in 1 CARTON (43068-606-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-609-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-608-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-607-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-611-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-605-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-604-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-603-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-602-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK

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": "5280b437-62d4-417f-bd65-eb8944a85166", "openfda": {"nui": ["N0000181815", "N0000181816"], "upc": ["0343068620019"], "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": ["0c025ba8-ba51-272e-e063-6294a90ad120"], "pharm_class_epc": ["Sphingosine 1-phosphate Receptor Modulator [EPC]"], "pharm_class_moa": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]"], "manufacturer_name": ["Vanda Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (43068-610-09)  *  1 BLISTER PACK in 1 CARTON (43068-606-00)  / 1 TABLET, FILM COATED in 1 BLISTER PACK *  1 BLISTER PACK in 1 CARTON (43068-609-00)  / 1 TABLET, FILM COATED in 1 BLISTER PACK *  1 BLISTER PACK in 1 CARTON (43068-608-00)  / 1 TABLET, FILM COATED in 1 BLISTER PACK *  1 BLISTER PACK in 1 CARTON (43068-607-00)  / 1 TABLET, FILM COATED in 1 BLISTER PACK *  1 BLISTER PACK in 1 CARTON (43068-611-00)  / 3 TABLET, FILM COATED in 1 BLISTER PACK *  1 BLISTER PACK in 1 CARTON (43068-605-00)  / 1 TABLET, FILM COATED in 1 BLISTER PACK *  1 BLISTER PACK in 1 CARTON (43068-604-00)  / 2 TABLET, FILM COATED in 1 BLISTER PACK *  1 BLISTER PACK in 1 CARTON (43068-603-00)  / 2 TABLET, FILM COATED in 1 BLISTER PACK *  1 BLISTER PACK in 1 CARTON (43068-602-00)  / 2 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "43068-610-09", "marketing_start_date": "20241101"}], "brand_name": "PONVORY", "product_id": "43068-610_5280b437-62d4-417f-bd65-eb8944a85166", "dosage_form": "KIT", "product_ndc": "43068-610", "generic_name": "Ponesimod", "labeler_name": "Vanda Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PONVORY", "application_number": "NDA213498", "marketing_category": "NDA", "marketing_start_date": "20210318", "listing_expiration_date": "20261231"}