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United States · US · US:69238-1380_28d97e13-000b-4f82-b42e-206c923ab057
Difluprednate
Orange BookUNIISPLATC D07AC19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeD07AC19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238138031 BOTTLE in 1 CARTON (69238-1380-3) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
S8A06QG2QE
DIFLUPREDNATE
RxCUI 23043
Orange Book
A211526
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": "69238-1380_28d97e13-000b-4f82-b42e-206c923ab057",
"productndc": "69238-1380",
"dosage_form": "EMULSION",
"orange_book": {
"appl_no": "211526",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Nov 17, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIFLUPREDNATE",
"proprietary_name": "Difluprednate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211526",
"marketing_category": "ANDA",
"nonproprietary_name": "Difluprednate ophthalmic",
"start_marketing_date": "20211118",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code D07AC19.
- 🇺🇸DifluprednateUpsher-Smith Laboratories, LLC
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- 🇺🇸DifluprednateAlembic Pharmaceuticals Inc.
- 🇺🇸DifluprednateMylan Pharmaceuticals Inc.
- 🇺🇸DIFLUPREDNATECipla USA Inc.
- 🇺🇸DIFLUPREDNATELeading Pharma, LLC
- 🇺🇸Difluprednate OphthalmicSandoz Inc
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