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United States · US · US:71930-088_a521d1c2-f4c3-4b7c-ba34-13e06d8ef71b

fludrocortisone acetate

Orange BookUNIISPLATC H02AA02

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

Identification

ManufacturerEywa Pharma Inc
CountryUS (United States)
ATC codeH02AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7193008812
    100 TABLET in 1 BOTTLE (71930-088-12)
  • ndc11
    7193008852
    500 TABLET in 1 BOTTLE (71930-088-52)

Annotations

UNII (FDA Substance ID)
V47IF0PVH4
FLUDROCORTISONE ACETATE
RxCUI 165516
Orange Book
A220308
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": "71930-088_a521d1c2-f4c3-4b7c-ba34-13e06d8ef71b",
  "productndc": "71930-088",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "220308",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG",
        "product_no": "001",
        "approval_date": "Feb 10, 2026"
      }
    ],
    "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": "ANDA220308",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fludrocortisone acetate",
  "start_marketing_date": "20250602",
  "active_numerator_strength": ".1"
}

Related drugs

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