🇺🇸
United States · US · US:0168-0059_7c4e6b9b-d444-4afe-a658-cdb4a6205ad2
Fluocinolone Acetonide
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11016800596060 mL in 1 BOTTLE (0168-0059-60)
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A088167
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": "0168-0059_7c4e6b9b-d444-4afe-a658-cdb4a6205ad2",
"productndc": "0168-0059",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "088167",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Dec 16, 1982"
}
],
"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": "ANDA088167",
"marketing_category": "ANDA",
"nonproprietary_name": "fluocinolone acetonide",
"start_marketing_date": "19821216",
"active_numerator_strength": ".1"
}Related drugs
Other records sharing ATC code S01BA15.
- 🇺🇸Derma-Smoothe/FSRoyal Pharmaceuticals, LLC
- 🇺🇸DERMA-SMOOTHE/FSRoyal Pharmaceuticals
- 🇺🇸DERMOTICRoyal Pharmaceuticals
- 🇺🇸Flac Otic OilPatrin Pharma, Inc.
- 🇺🇸fluocinolone acetonideANI Pharmaceuticals, Inc.
- 🇺🇸fluocinolone acetonidePadagis Israel Pharmaceuticals Ltd
- 🇺🇸fluocinolone acetonideANI Pharmaceuticals, Inc.
- 🇺🇸fluocinolone acetonideGlenmark Pharmaceuticals Inc., USA
Access this data programmatically
Query Fluocinolone Acetonide and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.