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United States · US · US:68999-730_4a935e59-bd47-9aae-e063-6394a90aad58

Fluoxetine

Orange BookUNIISPLATC N06AB03

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC
CountryUS (United States)
ATC codeN06AB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6899973024
    2 TRAY in 1 BOX (68999-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-730-45)

Annotations

UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A076458
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": "68999-730_4a935e59-bd47-9aae-e063-6394a90aad58",
  "productndc": "68999-730",
  "dosage_form": "LIQUID",
  "orange_book": {
    "appl_no": "076458",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE/5ML",
        "product_no": "001",
        "approval_date": "May 14, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOXETINE HYDROCHLORIDE",
  "proprietary_name": "Fluoxetine",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA076458",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluoxetine",
  "start_marketing_date": "20040514",
  "active_numerator_strength": "20"
}

Related drugs

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