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United States · US · US:72205-205_4e003e80-c860-4b03-81e2-6662324096d4

ziprasidone mesylate

Orange BookUNIISPLATC N05AE04

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

Identification

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

Packs · 1

  • ndc11
    7220520507
    10 VIAL, SINGLE-DOSE in 1 CARTON (72205-205-07) / 1 mL in 1 VIAL, SINGLE-DOSE (72205-205-01)

Annotations

UNII (FDA Substance ID)
3X6SAX83JZ
ZIPRASIDONE MESYLATE
RxCUI 353116
Orange Book
A216091
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": {
    "7e7261d7-4902-4bb5-a268-6c358890f963": {
      "match": "brand_token",
      "title": "ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "18",
      "published_date": "2026-05-25"
    }
  },
  "productid": "72205-205_4e003e80-c860-4b03-81e2-6662324096d4",
  "productndc": "72205-205",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "216091",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Sep 15, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZIPRASIDONE MESYLATE",
  "proprietary_name": "ziprasidone mesylate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216091",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ziprasidone mesylate",
  "start_marketing_date": "20220915",
  "active_numerator_strength": "20"
}

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