🇺🇸
United States · US · US:39328-079_b9a91a1b-2c51-4ef3-8152-7a720061b5aa
Flac Otic Oil
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPatrin Pharma, Inc.
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1139328079201 BOTTLE, DROPPER in 1 CARTON (39328-079-20) / 20 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A210736
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": "AURICULAR (OTIC)",
"spl_meta": {
"4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb": {
"match": "brand_token",
"title": "FLAC OTIC OIL (FLUOCINOLONE ACETONIDE) OIL [PATRIN PHARMA, INC.]",
"spl_version": "6",
"published_date": "2024-11-21"
}
},
"productid": "39328-079_b9a91a1b-2c51-4ef3-8152-7a720061b5aa",
"productndc": "39328-079",
"dosage_form": "OIL",
"orange_book": {
"appl_no": "210736",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Apr 11, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINOLONE ACETONIDE",
"proprietary_name": "Flac Otic Oil",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA210736",
"marketing_category": "ANDA",
"nonproprietary_name": "fluocinolone acetonide",
"start_marketing_date": "20180412",
"active_numerator_strength": ".11"
}Related drugs
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