🇺🇸
United States · US · US:0713-0709_ed968281-cd0d-65e8-e053-2a95a90a7054
FLUOCINOLONE ACETONIDE
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1107130709151 TUBE in 1 CARTON (0713-0709-15) / 15 g in 1 TUBE
- ndc1107130709601 TUBE in 1 CARTON (0713-0709-60) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A210747
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": "0713-0709_ed968281-cd0d-65e8-e053-2a95a90a7054",
"productndc": "0713-0709",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "210747",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.025%",
"product_no": "001",
"approval_date": "Nov 5, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINOLONE ACETONIDE",
"proprietary_name": "FLUOCINOLONE ACETONIDE",
"active_ingred_unit": "mg/g",
"application_number": "ANDA210747",
"marketing_category": "ANDA",
"nonproprietary_name": "FLUOCINOLONE ACETONIDE",
"start_marketing_date": "20181105",
"active_numerator_strength": ".25"
}Related drugs
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