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United States · US · US:0049-3920_c717f8ab-3351-4caa-b1fa-86c2fa415189

Geodon

Orange BookUNIISPLATC N05AE04

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

Identification

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

Packs · 1

  • ndc11
    0049392010
    10 VIAL, SINGLE-DOSE in 1 CARTON (0049-3920-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0049-3920-01)

Annotations

UNII (FDA Substance ID)
3X6SAX83JZ
ZIPRASIDONE MESYLATE
RxCUI 353116
Orange Book
N020919
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3X6SAX83JZ",
    "rxcui": "353116",
    "inchikey": "WLQZEFFFIUHSJB-UHFFFAOYSA-N",
    "display_name": "ZIPRASIDONE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "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": "0049-3920_c717f8ab-3351-4caa-b1fa-86c2fa415189",
  "productndc": "0049-3920",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "020919",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jun 21, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZIPRASIDONE MESYLATE",
  "proprietary_name": "Geodon",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020919",
  "marketing_category": "NDA",
  "nonproprietary_name": "ziprasidone mesylate",
  "start_marketing_date": "20031223",
  "active_numerator_strength": "20"
}

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