🇺🇸
United States · US · US:21922-003_2a5cbd76-85fe-4c9c-89b9-7c5924c82c6f
Fluocinolone Acetonide Topical Solution USP, 0.01%
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1121922003011 BOTTLE in 1 CARTON (21922-003-01) / 60 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A209913
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": "21922-003_2a5cbd76-85fe-4c9c-89b9-7c5924c82c6f",
"productndc": "21922-003",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "209913",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Feb 13, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINOLONE ACETONIDE",
"proprietary_name": "Fluocinolone Acetonide Topical Solution USP, 0.01%",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209913",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluocinolone Acetonide Topical Solution USP, 0.01%",
"start_marketing_date": "20190320",
"active_numerator_strength": ".1"
}Related drugs
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