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United States · US · US:65145-161_0f9a1987-6a04-4764-94e5-7053997c058b
Difluprednate
Orange BookUNIISPLATC D07AC19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeD07AC19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165145161011 BOTTLE in 1 CARTON (65145-161-01) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
S8A06QG2QE
DIFLUPREDNATE
RxCUI 23043
Orange Book
A219441
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": "65145-161_0f9a1987-6a04-4764-94e5-7053997c058b",
"productndc": "65145-161",
"dosage_form": "EMULSION",
"orange_book": {
"appl_no": "219441",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Dec 13, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIFLUPREDNATE",
"proprietary_name": "Difluprednate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA219441",
"marketing_category": "ANDA",
"nonproprietary_name": "Difluprednate",
"start_marketing_date": "20241226",
"active_numerator_strength": ".5"
}Related drugs
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