🇺🇸
United States · US · US:62332-750_2bc3d828-ffee-4526-a169-fb2bd39f0b7f
Difluprednate
Orange BookUNIISPLATC D07AC19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD07AC19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162332750051 BOTTLE in 1 CARTON (62332-750-05) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
S8A06QG2QE
DIFLUPREDNATE
RxCUI 23043
Orange Book
A213774
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": "62332-750_2bc3d828-ffee-4526-a169-fb2bd39f0b7f",
"productndc": "62332-750",
"dosage_form": "EMULSION",
"orange_book": {
"appl_no": "213774",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Jan 26, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIFLUPREDNATE",
"proprietary_name": "Difluprednate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA213774",
"marketing_category": "ANDA",
"nonproprietary_name": "difluprednate ophthalmic",
"start_marketing_date": "20260126",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code D07AC19.
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- 🇺🇸DifluprednateUpsher-Smith Laboratories, LLC
- 🇺🇸DIFLUPREDNATECipla USA Inc.
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- 🇺🇸Difluprednate OphthalmicSandoz Inc
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