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United States · US · US:63629-3331_3e3f03f9-e3d1-493d-b3d7-1f8215d6a9ee

Ziprasidone Hydrochloride

Orange BookUNIISPLATC N05AE04

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05AE04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6362933311
    60 CAPSULE in 1 BOTTLE (63629-3331-1)
  • ndc11
    6362933312
    28 CAPSULE in 1 BOTTLE (63629-3331-2)
  • ndc11
    6362933313
    30 CAPSULE in 1 BOTTLE (63629-3331-3)
  • ndc11
    6362933314
    90 CAPSULE in 1 BOTTLE (63629-3331-4)

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": "63629-3331_3e3f03f9-e3d1-493d-b3d7-1f8215d6a9ee",
  "productndc": "63629-3331",
  "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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