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United States · US · US:0832-6054_4af796ab-94c3-c22a-e063-6294a90abcb3
Difluprednate
Orange BookUNIISPLATC D07AC19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeD07AC19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1108326054051 BOTTLE in 1 CARTON (0832-6054-05) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
S8A06QG2QE
DIFLUPREDNATE
RxCUI 23043
Orange Book
A218191
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": "0832-6054_4af796ab-94c3-c22a-e063-6294a90abcb3",
"productndc": "0832-6054",
"dosage_form": "EMULSION",
"orange_book": {
"appl_no": "218191",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Feb 11, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIFLUPREDNATE",
"proprietary_name": "Difluprednate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218191",
"marketing_category": "ANDA",
"nonproprietary_name": "Difluprednate",
"start_marketing_date": "20250221",
"active_numerator_strength": ".5"
}Related drugs
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