CLOZAPINE

Orange BookUNIISPLATC N05AH02

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN05AH02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362923621
100 TABLET in 1 BOTTLE (63629-2362-1)

Annotations

UNII (FDA Substance ID)

J60AR2IKIC

CLOZAPINE

RxCUI 2626

Orange Book

A075713

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": "63629-2362_2a13d25a-9e81-4e2d-b110-d8c390b9caba",
  "productndc": "63629-2362",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075713",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 15, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Nov 15, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Aug 19, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Nov 7, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOZAPINE",
  "proprietary_name": "CLOZAPINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075713",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CLOZAPINE",
  "start_marketing_date": "20171108",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code N05AH02.

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