OLANZAPINE

Orange BookUNIISPLATC N05AH03

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

Identification

ManufacturerHEC Pharm USA Inc.

CountryUS (United States)

ATC codeN05AH03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7230308361
30 TABLET in 1 BOTTLE, PLASTIC (72303-0836-1)

Annotations

UNII (FDA Substance ID)

N7U69T4SZR

OLANZAPINE

RxCUI 61381

Orange Book

A206238

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "N7U69T4SZR",
    "rxcui": "61381",
    "inchikey": "KVWDHTXUZHCGIO-UHFFFAOYSA-N",
    "display_name": "OLANZAPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52b99337-afa8-a6f9-e063-6294a90a2038": {
      "match": "brand_token",
      "title": "OLANZAPINE TABLET, FILM COATED [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "72303-0836_4d2e9776-65f4-cb00-e063-6394a90a1bf7",
  "productndc": "72303-0836",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206238",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Nov 19, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Nov 19, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Nov 19, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Nov 19, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "005",
        "approval_date": "Nov 19, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Nov 19, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLANZAPINE",
  "proprietary_name": "OLANZAPINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206238",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olanzapine",
  "start_marketing_date": "20181130",
  "active_numerator_strength": "5"
}

Related drugs

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