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United States · US · US:62225-600_4ef3b158-3042-6a1f-e063-6394a90a807f
Omidria
Orange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOmeros Corporation
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
YZI5105V0L
KETOROLAC
RxCUI 35827
Orange Book
N205388
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YZI5105V0L",
"rxcui": "35827",
"inchikey": "OZWKMVRBQXNZKK-UHFFFAOYSA-N",
"display_name": "KETOROLAC",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAOCULAR",
"spl_meta": {
"21470688-4e81-4ea5-ac38-f72e10552e7e": {
"match": "brand_token",
"title": "OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]",
"spl_version": "16",
"published_date": "2026-05-11"
}
},
"productid": "62225-600_4ef3b158-3042-6a1f-e063-6394a90a807f",
"productndc": "62225-600",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "205388",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "EQ 0.3% BASE;EQ 1% BASE",
"product_no": "001",
"approval_date": "May 30, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOROLAC; PHENYLEPHRINE",
"proprietary_name": "Omidria",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA205388",
"marketing_category": "NDA",
"nonproprietary_name": "phenylephrine and ketorolac",
"start_marketing_date": "20140613",
"active_numerator_strength": "2.88; 10.16"
}Related drugs
Other records sharing ATC code M01AB.
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