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United States · US · US:66758-086_4dadac60-2b25-486b-b716-86516821678c
DUREZOL
Orange BookUNIISPLATC D07AC19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeD07AC19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1166758086751 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
S8A06QG2QE
DIFLUPREDNATE
RxCUI 23043
Orange Book
N022212
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "S8A06QG2QE",
"rxcui": "23043",
"inchikey": "WYQPLTPSGFELIB-JTQPXKBDSA-N",
"display_name": "DIFLUPREDNATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"ea520a27-f569-4b31-8bad-a25ad54b2caa": {
"match": "brand_token",
"title": "DUREZOL (DIFLUPREDNATE) EMULSION [SANDOZ INC]",
"spl_version": "4",
"published_date": "2025-11-17"
}
},
"productid": "66758-086_4dadac60-2b25-486b-b716-86516821678c",
"productndc": "66758-086",
"dosage_form": "EMULSION",
"orange_book": {
"appl_no": "022212",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Jun 23, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIFLUPREDNATE",
"proprietary_name": "DUREZOL",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022212",
"marketing_category": "NDA",
"nonproprietary_name": "difluprednate",
"start_marketing_date": "20110125",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code D07AC19.
- 🇺🇸DifluprednateUpsher-Smith Laboratories, LLC
- 🇺🇸DifluprednateAlembic Pharmaceuticals Limited
- 🇺🇸DifluprednateCaplin Steriles Limited
- 🇺🇸DifluprednateAlembic Pharmaceuticals Inc.
- 🇺🇸DifluprednateMylan Pharmaceuticals Inc.
- 🇺🇸DifluprednateAmneal Pharmaceuticals NY LLC
- 🇺🇸DIFLUPREDNATECipla USA Inc.
- 🇺🇸DIFLUPREDNATELeading Pharma, LLC
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