PONVORY

Orange BookUNIISPLATC L04AE04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerVanda Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL04AE04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4306862001
1 BOTTLE in 1 CARTON (43068-620-01) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

5G7AKV2MKP

PONESIMOD

RxCUI 2532300

Orange Book

N213498

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5G7AKV2MKP",
    "rxcui": "2532300",
    "inchikey": "LPAUOXUZGSBGDU-STDDISTJSA-N",
    "display_name": "PONESIMOD",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "43068-620_5280b437-62d4-417f-bd65-eb8944a85166",
  "productndc": "43068-620",
  "dosage_form": "TABLET, FILM COATED",
  "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": "PONESIMOD",
  "proprietary_name": "PONVORY",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213498",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ponesimod",
  "start_marketing_date": "20210318",
  "active_numerator_strength": "20"
}

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