Ziprasidone Hydrochloride

Orange BookUNIISPLATC N05AE04

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN05AE04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051807821
30 POUCH in 1 BOX (70518-0782-1) / 1 CAPSULE in 1 POUCH (70518-0782-2)

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": "70518-0782_4dc6932d-4bcd-63aa-e063-6394a90a90fb",
  "productndc": "70518-0782",
  "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": "20171011",
  "active_numerator_strength": "60"
}

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