Olanzapine and Fluoxetine

Orange BookUNIISPLATC N06AB

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeN06AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093550756
30 CAPSULE in 1 BOTTLE (0093-5507-56)

Annotations

UNII (FDA Substance ID)

I9W7N6B1KJ

FLUOXETINE HYDROCHLORIDE

RxCUI 227224

Orange Book

A077528

ABABABAB

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": "0093-5507_debcba63-033a-446f-a086-ccdf9d790662",
  "productndc": "0093-5507",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077528",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE;EQ 6MG BASE",
        "product_no": "001",
        "approval_date": "Jun 19, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE;EQ 12MG BASE",
        "product_no": "002",
        "approval_date": "Jun 19, 2012"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE;EQ 6MG BASE",
        "product_no": "003",
        "approval_date": "Jun 19, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE;EQ 12MG BASE",
        "product_no": "004",
        "approval_date": "Jun 19, 2012"
      }
    ],
    "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": "ANDA077528",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olanzapine and Fluoxetine",
  "start_marketing_date": "20120619",
  "active_numerator_strength": "50; 12"
}

Related drugs

Other records sharing ATC code N06AB.

Access this data programmatically

Query Olanzapine and Fluoxetine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs