Fluoxetine

Orange BookUNIISPLATC N06AB03

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

Identification

ManufacturerNorthwind Health Company, LLC

CountryUS (United States)

ATC codeN06AB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5165508126
90 CAPSULE in 1 BOTTLE, PLASTIC (51655-081-26)

Annotations

UNII (FDA Substance ID)

I9W7N6B1KJ

FLUOXETINE HYDROCHLORIDE

RxCUI 227224

Orange Book

A075465

AB1AB1AB

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": {
    "1a2a5194-b793-4c62-a177-040dad38526b": {
      "match": "brand_token",
      "title": "FLUOXETINE CAPSULE [PROFICIENT RX LP]",
      "spl_version": "6",
      "published_date": "2026-05-29"
    }
  },
  "productid": "51655-081_46ddcd42-e20e-656c-e063-6294a90a7e5f",
  "productndc": "51655-081",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075465",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jan 29, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jan 29, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Aug 2, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOXETINE HYDROCHLORIDE",
  "proprietary_name": "Fluoxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075465",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluoxetine Hydrochloride",
  "start_marketing_date": "20221004",
  "active_numerator_strength": "40"
}

Related drugs

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