Clozapine

Orange BookUNIISPLATC N05AH02

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

Identification

ManufacturerMylan Institutional Inc.

CountryUS (United States)

ATC codeN05AH02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5107974920
100 BLISTER PACK in 1 CARTON (51079-749-20) / 1 TABLET in 1 BLISTER PACK (51079-749-01)

Annotations

UNII (FDA Substance ID)

J60AR2IKIC

CLOZAPINE

RxCUI 2626

Orange Book

A075417

ABABABAB

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": "51079-749_4358c8d6-f05a-65d8-e063-6294a90a422a",
  "productndc": "51079-749",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075417",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 27, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "May 27, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "12.5MG",
        "product_no": "003",
        "approval_date": "Apr 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "Apr 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Apr 15, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOZAPINE",
  "proprietary_name": "Clozapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075417",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clozapine",
  "start_marketing_date": "20100706",
  "active_numerator_strength": "200"
}

Related drugs

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