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United States · US · US:42291-652_4135db41-e022-f3a8-e063-6394a90a3681

Olanzapine and Fluoxetine

Orange BookUNIISPLATC N06AB

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

Identification

ManufacturerAvKARE
CountryUS (United States)
ATC codeN06AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4229165230
    30 CAPSULE in 1 BOTTLE (42291-652-30)

Annotations

UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A202074
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "I9W7N6B1KJ",
    "rxcui": "227224",
    "inchikey": "GIYXAJPCNFJEHY-UHFFFAOYSA-N",
    "display_name": "FLUOXETINE HYDROCHLORIDE",
    "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": "42291-652_4135db41-e022-f3a8-e063-6394a90a3681",
  "productndc": "42291-652",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "202074",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE;EQ 3MG BASE",
        "product_no": "001",
        "approval_date": "Mar 25, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOXETINE HYDROCHLORIDE; OLANZAPINE",
  "proprietary_name": "Olanzapine and Fluoxetine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA202074",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olanzapine and Fluoxetine",
  "start_marketing_date": "20140121",
  "active_numerator_strength": "25; 3"
}

Related drugs

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