Fluoxetine

Orange BookUNIISPLATC N06AB03

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

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
7133510481
30 CAPSULE in 1 BOTTLE (71335-1048-1)
ndc11
7133510482
90 CAPSULE in 1 BOTTLE (71335-1048-2)
ndc11
7133510483
60 CAPSULE in 1 BOTTLE (71335-1048-3)
ndc11
7133510484
120 CAPSULE in 1 BOTTLE (71335-1048-4)
ndc11
7133510485
28 CAPSULE in 1 BOTTLE (71335-1048-5)
ndc11
7133510486
15 CAPSULE in 1 BOTTLE (71335-1048-6)
ndc11
7133510487
100 CAPSULE in 1 BOTTLE (71335-1048-7)
ndc11
7133510488
180 CAPSULE in 1 BOTTLE (71335-1048-8)

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": "71335-1048_09e143d4-493d-4143-b65e-e5329dca0a23",
  "productndc": "71335-1048",
  "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": "10"
}

Related drugs

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