Ziprasidone Hydrochloride

Orange BookUNIISPLATC N05AE04

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN05AE04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009054200
60 CAPSULE in 1 BOTTLE (50090-5420-0)

Annotations

UNII (FDA Substance ID)

216X081ORU

ZIPRASIDONE HYDROCHLORIDE

RxCUI 284925

Orange Book

A204375

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "216X081ORU",
    "rxcui": "284925",
    "inchikey": "ZCBZSCBNOOIHFP-UHFFFAOYSA-N",
    "display_name": "ZIPRASIDONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "50090-5420_a6511c1c-9700-4ce2-9ca2-f10cd1c96124",
  "productndc": "50090-5420",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204375",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Feb 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Feb 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Feb 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Feb 17, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZIPRASIDONE HYDROCHLORIDE",
  "proprietary_name": "Ziprasidone Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204375",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ziprasidone Hydrochloride",
  "start_marketing_date": "20170218",
  "active_numerator_strength": "40"
}

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