🇺🇸
United States · US · US:64980-331_f6254856-0b86-4d8d-9e92-66663f9f4d61
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
- ndc116498033104118.28 mL in 1 BOTTLE (64980-331-04)
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A203377
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": "64980-331_f6254856-0b86-4d8d-9e92-66663f9f4d61",
"productndc": "64980-331",
"dosage_form": "OIL",
"orange_book": {
"appl_no": "203377",
"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": "ANDA203377",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluocinolone Acetonide",
"start_marketing_date": "20160718",
"active_numerator_strength": ".11"
}Related drugs
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