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 · 3

ndc11
6586284601
100 TABLET in 1 BOTTLE (65862-846-01)
ndc11
6586284605
500 TABLET in 1 BOTTLE (65862-846-05)
ndc11
6586284678
10 BLISTER PACK in 1 CARTON (65862-846-78) / 10 TABLET in 1 BLISTER PACK (65862-846-10)

Annotations

UNII (FDA Substance ID)

J60AR2IKIC

CLOZAPINE

RxCUI 2626

Orange Book

A206433

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": "65862-846_a46da176-2ed3-4b9a-b06f-efab2936a5ee",
  "productndc": "65862-846",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206433",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Nov 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Nov 29, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOZAPINE",
  "proprietary_name": "CLOZAPINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206433",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CLOZAPINE",
  "start_marketing_date": "20161129",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N05AH02.

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