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United States · US · US:70771-1893_3d915d99-8d45-4077-990f-da0f653675a2
Fludrocortisone acetate
Orange BookUNIISPLATC H02AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeH02AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117077118931100 TABLET in 1 BOTTLE (70771-1893-1)
- ndc117077118935500 TABLET in 1 BOTTLE (70771-1893-5)
Annotations
UNII (FDA Substance ID)
V47IF0PVH4
FLUDROCORTISONE ACETATE
RxCUI 165516
Orange Book
A219251
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": "70771-1893_3d915d99-8d45-4077-990f-da0f653675a2",
"productndc": "70771-1893",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219251",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1MG",
"product_no": "001",
"approval_date": "Oct 16, 2024"
}
],
"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": "ANDA219251",
"marketing_category": "ANDA",
"nonproprietary_name": "Fludrocortisone acetate",
"start_marketing_date": "20241202",
"active_numerator_strength": ".1"
}Related drugs
Other records sharing ATC code H02AA02.
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