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United States · US · US:68611-180_f684c980-0cfe-11f1-b4ac-0800200c9a66
YUTIQ
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168611180011 POUCH in 1 CARTON (68611-180-01) / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
N210331
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": "INTRAVITREAL",
"spl_meta": {
"f270cad8-ed82-4969-b785-831a1910bfa6": {
"match": "brand_token",
"title": "YUTIQ (FLUOCINOLONE ACETONIDE) IMPLANT [ANI PHARMACEUTICALS, INC.]",
"spl_version": "4",
"published_date": "2026-02-23"
}
},
"productid": "68611-180_f684c980-0cfe-11f1-b4ac-0800200c9a66",
"productndc": "68611-180",
"dosage_form": "IMPLANT",
"orange_book": {
"appl_no": "210331",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.18MG",
"product_no": "001",
"approval_date": "Oct 12, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINOLONE ACETONIDE",
"proprietary_name": "YUTIQ",
"active_ingred_unit": "mg/1",
"application_number": "NDA210331",
"marketing_category": "NDA",
"nonproprietary_name": "FLUOCINOLONE ACETONIDE",
"start_marketing_date": "20230517",
"active_numerator_strength": ".18"
}Related drugs
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