Olanzapine and Fluoxetine

Orange BookUNIISPLATC N06AB

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

Identification

ManufacturerPar Health USA, LLC

CountryUS (United States)

ATC codeN06AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4988425111
30 CAPSULE in 1 BOTTLE, PLASTIC (49884-251-11)

Annotations

UNII (FDA Substance ID)

I9W7N6B1KJ

FLUOXETINE HYDROCHLORIDE

RxCUI 227224

Orange Book

A077742

ABABABABAB

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": "49884-251_d4b26d87-0345-449f-88c1-2d6a9eefd699",
  "productndc": "49884-251",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077742",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE;EQ 3MG BASE",
        "product_no": "001",
        "approval_date": "Nov 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE;EQ 6MG BASE",
        "product_no": "002",
        "approval_date": "Nov 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE;EQ 12MG BASE",
        "product_no": "003",
        "approval_date": "Nov 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE;EQ 6MG BASE",
        "product_no": "004",
        "approval_date": "Nov 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE;EQ 12MG BASE",
        "product_no": "005",
        "approval_date": "Nov 2, 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": "ANDA077742",
  "marketing_category": "ANDA",
  "nonproprietary_name": "olanzapine and fuoxetine",
  "start_marketing_date": "20121126",
  "active_numerator_strength": "50; 6"
}

Related drugs

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