🇺🇸
United States · US · US:68462-185_cc1f615e-6cb2-4721-84c6-e5f170b64d90
fluocinolone acetonide
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462185561 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A211815
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": "68462-185_cc1f615e-6cb2-4721-84c6-e5f170b64d90",
"productndc": "68462-185",
"dosage_form": "OIL",
"orange_book": {
"appl_no": "211815",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.01%",
"product_no": "001",
"approval_date": "Dec 14, 2018"
}
],
"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": "ANDA211815",
"marketing_category": "ANDA",
"nonproprietary_name": "fluocinolone acetonide",
"start_marketing_date": "20181218",
"active_numerator_strength": ".11"
}Related drugs
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