ziprasidone hydrochloride

Orange BookUNIISPLATC N05AE04

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

Identification

ManufacturerAvPAK

CountryUS (United States)

ATC codeN05AE04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026881412
20 BLISTER PACK in 1 BOX (50268-814-12) / 1 CAPSULE in 1 BLISTER PACK (50268-814-11)

Annotations

UNII (FDA Substance ID)

216X081ORU

ZIPRASIDONE HYDROCHLORIDE

RxCUI 284925

Orange Book

A077561

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": "50268-814_4837897c-231e-1f6b-e063-6294a90a291c",
  "productndc": "50268-814",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077561",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Mar 2, 2012"
      }
    ],
    "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": "ANDA077561",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ziprasidone HCl",
  "start_marketing_date": "20210512",
  "active_numerator_strength": "80"
}

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