Olanzapine

Orange BookUNIISPLATC N05AH03

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN05AH03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6318784403
3 TABLET, FILM COATED in 1 BOTTLE (63187-844-03)
ndc11
6318784430
30 TABLET, FILM COATED in 1 BOTTLE (63187-844-30)
ndc11
6318784460
60 TABLET, FILM COATED in 1 BOTTLE (63187-844-60)
ndc11
6318784490
90 TABLET, FILM COATED in 1 BOTTLE (63187-844-90)

Annotations

UNII (FDA Substance ID)

N7U69T4SZR

OLANZAPINE

RxCUI 61381

Orange Book

A090798

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": "63187-844_e818889d-6a4e-473d-90cc-f817ffece059",
  "productndc": "63187-844",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090798",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "005",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Apr 23, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLANZAPINE",
  "proprietary_name": "Olanzapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090798",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olanzapine",
  "start_marketing_date": "20120423",
  "active_numerator_strength": "5"
}

Related drugs

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