Clozapine

Orange BookUNIISPLATC N05AH02

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN05AH02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5965126301
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-263-01)
ndc11
5965126348
8 BLISTER PACK in 1 CARTON (59651-263-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

J60AR2IKIC

CLOZAPINE

RxCUI 2626

Orange Book

A212923

ABABABABAB

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": {
    "883b5d43-0339-7dc1-f775-93791fb9b978": {
      "match": "brand_token",
      "title": "CLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "35",
      "published_date": "2026-05-15"
    }
  },
  "productid": "59651-263_5fe42ada-7ea2-4b77-bad5-93e1b1fb765d",
  "productndc": "59651-263",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "212923",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Dec 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Dec 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Dec 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "004",
        "approval_date": "Dec 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Dec 12, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOZAPINE",
  "proprietary_name": "Clozapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212923",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clozapine",
  "start_marketing_date": "20241212",
  "active_numerator_strength": "150"
}

Related drugs

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