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United States · US · US:71335-0924_ffe74518-5a6e-4a92-ae3f-41fb7af9b642

Fluoxetine

Orange BookUNIISPLATC N06AB03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06AB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133509241
    30 CAPSULE in 1 BOTTLE (71335-0924-1)
  • ndc11
    7133509242
    100 CAPSULE in 1 BOTTLE (71335-0924-2)
  • ndc11
    7133509243
    60 CAPSULE in 1 BOTTLE (71335-0924-3)
  • ndc11
    7133509244
    15 CAPSULE in 1 BOTTLE (71335-0924-4)
  • ndc11
    7133509245
    56 CAPSULE in 1 BOTTLE (71335-0924-5)
  • ndc11
    7133509246
    28 CAPSULE in 1 BOTTLE (71335-0924-6)
  • ndc11
    7133509247
    90 CAPSULE in 1 BOTTLE (71335-0924-7)
  • ndc11
    7133509248
    120 CAPSULE in 1 BOTTLE (71335-0924-8)
  • ndc11
    7133509249
    45 CAPSULE in 1 BOTTLE (71335-0924-9)

Annotations

UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A076001
AB1AB1
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": "71335-0924_ffe74518-5a6e-4a92-ae3f-41fb7af9b642",
  "productndc": "71335-0924",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076001",
    "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"
      }
    ],
    "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": "ANDA076001",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluoxetine",
  "start_marketing_date": "20020129",
  "active_numerator_strength": "20"
}

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