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United States · US · US:55111-167_e0d25a13-d2e2-0299-98bb-4d523d75cb76

Olanzapine

Orange BookUNIISPLATC N05AH03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerDr. Reddy's Laboratories Ltd.
CountryUS (United States)
ATC codeN05AH03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5511116701
    100 TABLET, FILM COATED in 1 BOTTLE (55111-167-01)
  • ndc11
    5511116705
    500 TABLET, FILM COATED in 1 BOTTLE (55111-167-05)
  • ndc11
    5511116730
    30 TABLET, FILM COATED in 1 BOTTLE (55111-167-30)
  • ndc11
    5511116778
    10 BLISTER PACK in 1 CARTON (55111-167-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-167-79)

Annotations

UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
A076133
ABAB
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": "55111-167_e0d25a13-d2e2-0299-98bb-4d523d75cb76",
  "productndc": "55111-167",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076133",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Oct 24, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLANZAPINE",
  "proprietary_name": "Olanzapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076133",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olanzapine",
  "start_marketing_date": "20120423",
  "active_numerator_strength": "15"
}

Related drugs

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