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United States · US · US:52817-601_38837e2a-084f-4179-e063-6394a90afd45

VERSACLOZ

Orange BookUNIISPLATC N05AH02

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

Identification

ManufacturerTruPharma LLC
CountryUS (United States)
ATC codeN05AH02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5281760138
    1 BOTTLE in 1 BOX (52817-601-38) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
J60AR2IKIC
CLOZAPINE
RxCUI 2626
Orange Book
N203479
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "J60AR2IKIC",
    "rxcui": "2626",
    "inchikey": "QZUDBNBUXVUHMW-UHFFFAOYSA-N",
    "display_name": "CLOZAPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2592c9a8-fd74-4e0d-a895-b07b014cf355": {
      "match": "brand_token",
      "title": "VERSACLOZ (CLOZAPINE) SUSPENSION [TRUPHARMA LLC]",
      "spl_version": "6",
      "published_date": "2025-06-30"
    }
  },
  "productid": "52817-601_38837e2a-084f-4179-e063-6394a90afd45",
  "productndc": "52817-601",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "203479",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Feb 6, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOZAPINE",
  "proprietary_name": "VERSACLOZ",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA203479",
  "marketing_category": "NDA",
  "nonproprietary_name": "Clozapine",
  "start_marketing_date": "20180615",
  "active_numerator_strength": "50"
}

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