🇺🇸
United States · US · US:43598-588_acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6
Difluprednate Ophthalmic Emulsion
Orange BookUNIISPLATC D07AC19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeD07AC19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143598588111 BOTTLE in 1 CARTON (43598-588-11) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
S8A06QG2QE
DIFLUPREDNATE
RxCUI 23043
Orange Book
A214894
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": "43598-588_acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6",
"productndc": "43598-588",
"dosage_form": "EMULSION",
"orange_book": {
"appl_no": "214894",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Nov 16, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIFLUPREDNATE",
"proprietary_name": "Difluprednate Ophthalmic Emulsion",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214894",
"marketing_category": "ANDA",
"nonproprietary_name": "Difluprednate Ophthalmic",
"start_marketing_date": "20221225",
"active_numerator_strength": ".5"
}Related drugs
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