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United States · US · US:51672-5306_135b375a-b00e-72c3-e063-6394a90af4f3

FLUOXETINE HYDROCHLORIDE

Orange BookUNIISPLATC N06AB03

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

Identification

ManufacturerTaro Pharmaceuticals U.S.A., Inc.
CountryUS (United States)
ATC codeN06AB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5167253062
    500 TABLET, FILM COATED in 1 BOTTLE (51672-5306-2)
  • ndc11
    5167253066
    30 TABLET, FILM COATED in 1 BOTTLE (51672-5306-6)

Annotations

UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A211477
AB
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": "51672-5306_135b375a-b00e-72c3-e063-6394a90af4f3",
  "productndc": "51672-5306",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211477",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "001",
        "approval_date": "Nov 21, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOXETINE HYDROCHLORIDE",
  "proprietary_name": "FLUOXETINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211477",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FLUOXETINE HYDROCHLORIDE",
  "start_marketing_date": "20190215",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code N06AB03.

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