🇺🇸
United States · US · US:0781-6000_6ae7a5b2-4844-4a63-a95e-8dd76c1e3653
Difluprednate Ophthalmic
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
- ndc1107816000781 BOTTLE in 1 CARTON (0781-6000-78) / 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": {
"4a3b2649-ee3d-4648-91c8-912a8ba2e73c": {
"match": "brand_token",
"title": "DIFLUPREDNATE EMULSION [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "2",
"published_date": "2026-04-20"
}
},
"productid": "0781-6000_6ae7a5b2-4844-4a63-a95e-8dd76c1e3653",
"productndc": "0781-6000",
"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": "Difluprednate Ophthalmic",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022212",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Difluprednate Ophthalmic",
"start_marketing_date": "20130515",
"active_numerator_strength": ".5"
}Related drugs
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