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United States · US · US:0904-7317_9e36ef12-d8e2-4a21-a1f0-3bc95fe9e557
Fludrocortisone Acetate
Orange BookUNIISPLATC H02AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeH02AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11090473170650 BLISTER PACK in 1 CARTON (0904-7317-06) / 1 TABLET in 1 BLISTER PACK
- ndc110904731761100 BLISTER PACK in 1 CARTON (0904-7317-61) / 1 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
V47IF0PVH4
FLUDROCORTISONE ACETATE
RxCUI 165516
Orange Book
A215279
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": "0904-7317_9e36ef12-d8e2-4a21-a1f0-3bc95fe9e557",
"productndc": "0904-7317",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215279",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1MG",
"product_no": "001",
"approval_date": "May 31, 2022"
}
],
"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": "ANDA215279",
"marketing_category": "ANDA",
"nonproprietary_name": "Fludrocortisone Acetate",
"start_marketing_date": "20240904",
"active_numerator_strength": ".1"
}Related drugs
Other records sharing ATC code H02AA02.
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