🇺🇸
United States · US · US:0591-2990_8c1b96a1-47e6-4fac-9bda-0b299ac25800
Fluocinolone Acetonide Topical
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105912990601 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2990-60) / 60 mL in 1 BOTTLE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A208386
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": "0591-2990_8c1b96a1-47e6-4fac-9bda-0b299ac25800",
"productndc": "0591-2990",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "208386",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.01%",
"product_no": "001",
"approval_date": "Oct 21, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINOLONE ACETONIDE",
"proprietary_name": "Fluocinolone Acetonide Topical",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA208386",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluocinolone Acetonide Topical",
"start_marketing_date": "20161207",
"active_numerator_strength": ".1"
}Related drugs
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