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United States · US · US:59572-890_4f94fc7c-c65f-6879-e063-6294a90a8217

ZEPOSIA

Orange BookSPL

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

Identification

ManufacturerCelgene Corporation
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5957289028
    1 KIT in 1 CARTON (59572-890-28) * 1 CAPSULE in 1 BLISTER PACK * 21 CAPSULE in 1 BOTTLE, PLASTIC * 1 CAPSULE in 1 BLISTER PACK
  • ndc11
    5957289098
    1 KIT in 1 CARTON (59572-890-98) * 1 CAPSULE in 1 BLISTER PACK * 21 CAPSULE in 1 BOTTLE, PLASTIC * 1 CAPSULE in 1 BLISTER PACK

Annotations

Orange Book
N209899
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "59572-890_4f94fc7c-c65f-6879-e063-6294a90a8217",
  "productndc": "59572-890",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "ZEPOSIA",
  "active_ingred_unit": null,
  "application_number": "NDA209899",
  "marketing_category": "NDA",
  "nonproprietary_name": "ozanimod hydrochloride",
  "start_marketing_date": "20200327",
  "active_numerator_strength": null
}

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