ZEPOSIA

Orange BookUNIISPLATC L04AE02

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

Identification

ManufacturerCelgene Corporation

CountryUS (United States)

ATC codeL04AE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5957282030
30 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-30)

Annotations

UNII (FDA Substance ID)

3UPR33JAAM

OZANIMOD HYDROCHLORIDE

RxCUI 2288235

Orange Book

N209899

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3UPR33JAAM",
    "rxcui": "2288235",
    "inchikey": "HAOOCAKHSFYDBU-BDQAORGHSA-N",
    "display_name": "OZANIMOD HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "93ce2fab-edfb-4804-8074-963071de51e4": {
      "match": "brand_token",
      "title": "ZEPOSIA (OZANIMOD HYDROCHLORIDE) CAPSULE ZEPOSIA 7-DAY STARTER PACK (OZANIMOD HYDROCHLORIDE) KIT ZEPOSIA STARTER KIT (OZANIMOD HYDROCHLORIDE) KIT [CELGENE CORPORATION]",
      "spl_version": "25",
      "published_date": "2026-04-17"
    }
  },
  "productid": "59572-820_4f94fc7c-c65f-6879-e063-6294a90a8217",
  "productndc": "59572-820",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209899",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.23MG BASE",
        "product_no": "001",
        "approval_date": "Mar 25, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.46MG BASE",
        "product_no": "002",
        "approval_date": "Mar 25, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.92MG BASE",
        "product_no": "003",
        "approval_date": "Mar 25, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OZANIMOD HYDROCHLORIDE",
  "proprietary_name": "ZEPOSIA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209899",
  "marketing_category": "NDA",
  "nonproprietary_name": "ozanimod hydrochloride",
  "start_marketing_date": "20200327",
  "active_numerator_strength": ".92"
}

Related drugs

Other records sharing ATC code L04AE02.

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