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United States · US · US:43068-610_5280b437-62d4-417f-bd65-eb8944a85166
PONVORY
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVanda Pharmaceuticals Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143068610091 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
Annotations
Orange Book
N213498
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"0c025ba8-ba51-272e-e063-6294a90ad120": {
"match": "brand_token",
"title": "PONVORY (PONESIMOD) TABLET, FILM COATED PONVORY (PONESIMOD) KIT [VANDA PHARMACEUTICALS INC.]",
"spl_version": "4",
"published_date": "2025-12-12"
}
},
"productid": "43068-610_5280b437-62d4-417f-bd65-eb8944a85166",
"productndc": "43068-610",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "213498",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "3MG",
"product_no": "002",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "4MG",
"product_no": "003",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "004",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "6MG",
"product_no": "005",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "7MG",
"product_no": "006",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "8MG",
"product_no": "007",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "9MG",
"product_no": "008",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "009",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "010",
"approval_date": "Mar 18, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "PONVORY",
"active_ingred_unit": null,
"application_number": "NDA213498",
"marketing_category": "NDA",
"nonproprietary_name": "Ponesimod",
"start_marketing_date": "20210318",
"active_numerator_strength": null
}Access this data programmatically
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