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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
- ndc110115703301100 TABLET in 1 BOTTLE (0115-7033-01)
- ndc110115703302500 TABLET in 1 BOTTLE (0115-7033-02)
- ndc1101157033031000 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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