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United States · US · US:72241-009_f35d566f-6a36-4ba8-8f78-6c1d79900e9a

Fluoxetine

Orange BookUNIISPLATC N06AB03

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

Identification

ManufacturerModavar Pharmaceuticals LLC
CountryUS (United States)
ATC codeN06AB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7224100905
    100 CAPSULE in 1 BOTTLE (72241-009-05)
  • ndc11
    7224100910
    500 CAPSULE in 1 BOTTLE (72241-009-10)
  • ndc11
    7224100922
    30 CAPSULE in 1 BOTTLE (72241-009-22)

Annotations

UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A206993
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": "72241-009_f35d566f-6a36-4ba8-8f78-6c1d79900e9a",
  "productndc": "72241-009",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206993",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "May 23, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "May 23, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "May 23, 2019"
      }
    ],
    "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": "ANDA206993",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluoxetine",
  "start_marketing_date": "20210908",
  "active_numerator_strength": "40"
}

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