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United States · US · US:0115-7033_1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037

Fludrocortisone Acetate

Orange BookUNIISPLATC H02AA02

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeH02AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0115703301
    100 TABLET in 1 BOTTLE (0115-7033-01)
  • ndc11
    0115703302
    500 TABLET in 1 BOTTLE (0115-7033-02)
  • ndc11
    0115703303
    1000 TABLET in 1 BOTTLE (0115-7033-03)

Annotations

UNII (FDA Substance ID)
V47IF0PVH4
FLUDROCORTISONE ACETATE
RxCUI 165516
Orange Book
A040431
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V47IF0PVH4",
    "rxcui": "165516",
    "inchikey": "SYWHXTATXSMDSB-GSLJADNHSA-N",
    "display_name": "FLUDROCORTISONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "89b5687a-6e21-47cd-9c05-d9c9f4f8cf49": {
      "match": "brand_token",
      "title": "FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH 107, LLC]",
      "spl_version": "15",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0115-7033_1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037",
  "productndc": "0115-7033",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040431",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG",
        "product_no": "001",
        "approval_date": "Mar 18, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUDROCORTISONE ACETATE",
  "proprietary_name": "Fludrocortisone Acetate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040431",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FLUDROCORTISONE ACETATE",
  "start_marketing_date": "20020318",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code H02AA02.

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