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United States · US · US:0069-0274_c2b3ca10-be3d-4c1c-b210-9ebefc065826

Velsipity

Orange BookUNIISPLATC L04AE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeL04AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0069027430
    1 BOTTLE in 1 CARTON (0069-0274-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
MXE5EMA09L
ETRASIMOD ARGININE
Orange Book
N216956
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MXE5EMA09L",
    "rxcui": null,
    "inchikey": "GVPVVOSNDUAUKM-BPGOJFKZSA-N",
    "display_name": "ETRASIMOD ARGININE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d5b2a717-1b5c-4aed-a69c-64a0c4561c40": {
      "match": "brand_token",
      "title": "VELSIPITY (ETRASIMOD) TABLET, FILM COATED [U.S. PHARMACEUTICALS]",
      "spl_version": "4",
      "published_date": "2026-02-05"
    }
  },
  "productid": "0069-0274_c2b3ca10-be3d-4c1c-b210-9ebefc065826",
  "productndc": "0069-0274",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216956",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Oct 12, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETRASIMOD ARGININE",
  "proprietary_name": "Velsipity",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216956",
  "marketing_category": "NDA",
  "nonproprietary_name": "etrasimod",
  "start_marketing_date": "20231019",
  "active_numerator_strength": "2"
}

Related drugs

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