🇺🇸
United States · US · US:0168-0064_2034c4ef-c138-44bd-9101-a7b7660f9d18
Fluocinolone Acetonide
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11016800641515 g in 1 TUBE (0168-0064-15)
- ndc11016800646060 g in 1 TUBE (0168-0064-60)
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A088168
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0CD5FD6S2M",
"rxcui": "4461",
"inchikey": "FEBLZLNTKCEFIT-VSXGLTOVSA-N",
"display_name": "FLUOCINOLONE ACETONIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"4790bdfa-c964-4c3e-9d01-c2fb23a0172e": {
"match": "brand_token",
"title": "FLUOCINOLONE ACETONIDE OIL [BRYANT RANCH PREPACK]",
"spl_version": "104",
"published_date": "2026-05-28"
}
},
"productid": "0168-0064_2034c4ef-c138-44bd-9101-a7b7660f9d18",
"productndc": "0168-0064",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "088168",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.025%",
"product_no": "001",
"approval_date": "Dec 16, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINOLONE ACETONIDE",
"proprietary_name": "Fluocinolone Acetonide",
"active_ingred_unit": "mg/g",
"application_number": "ANDA088168",
"marketing_category": "ANDA",
"nonproprietary_name": "fluocinolone acetonide",
"start_marketing_date": "19821216",
"active_numerator_strength": ".25"
}Related drugs
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