🇺🇸
United States · US · US:64980-329_4e01be19-15cd-4b8f-bbae-158c27b556f3
Fluocinolone Acetonide
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11649803292020 mL in 1 BOTTLE (64980-329-20)
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A203378
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": "64980-329_4e01be19-15cd-4b8f-bbae-158c27b556f3",
"productndc": "64980-329",
"dosage_form": "OIL",
"orange_book": {
"appl_no": "203378",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Apr 25, 2016"
}
],
"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": "ANDA203378",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluocinolone Acetonide",
"start_marketing_date": "20160914",
"active_numerator_strength": ".11"
}Related drugs
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