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United States · US · US:58151-134_8351d3a9-c9f8-4ae0-be80-ae3a4ef02820

Geodon

Orange BookUNIISPLATC N05AE04

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

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN05AE04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5815113491
    60 CAPSULE in 1 BOTTLE (58151-134-91)

Annotations

UNII (FDA Substance ID)
6UKA5VEJ6X
ZIPRASIDONE
RxCUI 115698
Orange Book
N020825
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6UKA5VEJ6X",
    "rxcui": "115698",
    "inchikey": "MVWVFYHBGMAFLY-UHFFFAOYSA-N",
    "display_name": "ZIPRASIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a2b4cc65-6a6d-49c4-adfc-a4458562a167": {
      "match": "brand_token",
      "title": "GEODON (ZIPRASIDONE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIATRIS SPECIALTY LLC]",
      "spl_version": "2",
      "published_date": "2026-04-17"
    }
  },
  "productid": "58151-134_8351d3a9-c9f8-4ae0-be80-ae3a4ef02820",
  "productndc": "58151-134",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "020825",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Feb 5, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Feb 5, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Feb 5, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Feb 5, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZIPRASIDONE",
  "proprietary_name": "Geodon",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020825",
  "marketing_category": "NDA",
  "nonproprietary_name": "ziprasidone",
  "start_marketing_date": "20260415",
  "active_numerator_strength": "80"
}

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