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 · 2

ndc11
7051822940
30 CAPSULE in 1 BLISTER PACK (70518-2294-0)
ndc11
7051822941
30 POUCH in 1 BOX (70518-2294-1) / 1 CAPSULE in 1 POUCH (70518-2294-2)

Annotations

UNII (FDA Substance ID)

216X081ORU

ZIPRASIDONE HYDROCHLORIDE

RxCUI 284925

Orange Book

A077565

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": "70518-2294_52564e2f-97e6-89ba-e063-6394a90ab424",
  "productndc": "70518-2294",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077565",
    "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": "ANDA077565",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ziprasidone hydrochloride",
  "start_marketing_date": "20190903",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code N05AE04.

Access this data programmatically

Query ziprasidone hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs