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United States · US · US:63187-578_df562b71-4edb-4e13-bf1e-23031eaf0975

ziprasidone hydrochloride

Orange BookUNIISPLATC N05AE04

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN05AE04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6318757830
    30 CAPSULE in 1 BOTTLE (63187-578-30)
  • ndc11
    6318757860
    60 CAPSULE in 1 BOTTLE (63187-578-60)
  • ndc11
    6318757890
    90 CAPSULE in 1 BOTTLE (63187-578-90)

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": "63187-578_df562b71-4edb-4e13-bf1e-23031eaf0975",
  "productndc": "63187-578",
  "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": "20120514",
  "active_numerator_strength": "60"
}

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