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United States · US · US:50090-6702_57eb3004-f630-4418-a421-c235024c74b3

Fluoxetine

Orange BookUNIISPLATC N06AB03

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN06AB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009067020
    30 CAPSULE in 1 BOTTLE (50090-6702-0)
  • ndc11
    5009067022
    90 CAPSULE in 1 BOTTLE (50090-6702-2)

Annotations

UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A204597
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": "50090-6702_57eb3004-f630-4418-a421-c235024c74b3",
  "productndc": "50090-6702",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204597",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 16, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Mar 16, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Mar 16, 2015"
      }
    ],
    "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": "ANDA204597",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluoxetine Hydrochloride",
  "start_marketing_date": "20190925",
  "active_numerator_strength": "10"
}

Related drugs

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