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United States · US · US:84826-002_33504c5f-664b-4f6b-e063-6294a90a2aea
Omlonti
Orange BookUNIISPLATC S01EX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOcuvex Therapeutics, Inc.
CountryUS (United States)
ATC codeS01EX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1184826002011 BOTTLE, PLASTIC in 1 CARTON (84826-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC
- ndc1184826002033 BOTTLE, PLASTIC in 1 CARTON (84826-002-03) / 2.5 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
G0G0H52U6K
OMIDENEPAG ISOPROPYL
RxCUI 2612690
Orange Book
N215092
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G0G0H52U6K",
"rxcui": "2612690",
"inchikey": "VIQCWEGEHRBLAC-UHFFFAOYSA-N",
"display_name": "OMIDENEPAG ISOPROPYL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"4258e437-7e92-4b09-baf1-01cb158cfc05": {
"match": "brand_token",
"title": "OMLONTI (OMIDENEPAG ISOPROPYL) SOLUTION/ DROPS [OCUVEX THERAPEUTICS, INC.]",
"spl_version": "3",
"published_date": "2025-04-23"
}
},
"productid": "84826-002_33504c5f-664b-4f6b-e063-6294a90a2aea",
"productndc": "84826-002",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "215092",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.002%",
"product_no": "001",
"approval_date": "Sep 22, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OMIDENEPAG ISOPROPYL",
"proprietary_name": "Omlonti",
"active_ingred_unit": "mg/mL",
"application_number": "NDA215092",
"marketing_category": "NDA",
"nonproprietary_name": "omidenepag isopropyl",
"start_marketing_date": "20220923",
"active_numerator_strength": ".02"
}Access this data programmatically
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