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United States · US · US:82604-600_ffe62883-85a4-6e94-e053-6294a90ac61f
Omidria
Orange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRayner Surgical Inc.
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1182604600001 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL
- ndc1182604600044 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL
- ndc1182604600994 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL
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": "82604-600_ffe62883-85a4-6e94-e053-6294a90ac61f",
"productndc": "82604-600",
"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": "20230701",
"active_numerator_strength": "2.88; 10.16"
}Related drugs
Other records sharing ATC code M01AB.
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