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United States · US · US:71335-1548_c1d88c7e-4490-4618-9d78-93be301e14c6

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 · 8

  • ndc11
    7133515481
    30 CAPSULE in 1 BOTTLE (71335-1548-1)
  • ndc11
    7133515482
    90 CAPSULE in 1 BOTTLE (71335-1548-2)
  • ndc11
    7133515483
    60 CAPSULE in 1 BOTTLE (71335-1548-3)
  • ndc11
    7133515484
    120 CAPSULE in 1 BOTTLE (71335-1548-4)
  • ndc11
    7133515485
    28 CAPSULE in 1 BOTTLE (71335-1548-5)
  • ndc11
    7133515486
    15 CAPSULE in 1 BOTTLE (71335-1548-6)
  • ndc11
    7133515487
    100 CAPSULE in 1 BOTTLE (71335-1548-7)
  • ndc11
    7133515488
    180 CAPSULE in 1 BOTTLE (71335-1548-8)

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": "71335-1548_c1d88c7e-4490-4618-9d78-93be301e14c6",
  "productndc": "71335-1548",
  "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": "20150316",
  "active_numerator_strength": "10"
}

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