🇺🇸
United States · US · US:45802-009_8512259d-c8ce-4b9c-ad3b-0d97b9a86077
Fluocinolone Acetonide
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1145802009101 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A202849
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": "AURICULAR (OTIC)",
"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": "45802-009_8512259d-c8ce-4b9c-ad3b-0d97b9a86077",
"productndc": "45802-009",
"dosage_form": "OIL",
"orange_book": {
"appl_no": "202849",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Jul 17, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINOLONE ACETONIDE",
"proprietary_name": "Fluocinolone Acetonide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA202849",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluocinolone Acetonide",
"start_marketing_date": "20171004",
"active_numerator_strength": ".11"
}Related drugs
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