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United States · US · US:69315-260_aedd35df-9c0a-4dfb-ac09-dcb63675a420
KETOROLAC TROMETHAMINE
In shortageOrange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116931526001100 TABLET, FILM COATED in 1 BOTTLE (69315-260-01)
Annotations
UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A215745
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ketorolac Tromethamine Injection
Raw payload (JSON)
{
"unii": {
"unii": "4EVE5946BQ",
"rxcui": "28200",
"inchikey": "BWHLPLXXIDYSNW-UHFFFAOYSA-N",
"display_name": "KETOROLAC TROMETHAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"521b3d09-df08-fcae-e063-6294a90a6545": {
"match": "brand_token",
"title": "KETOROLAC TROMETHAMINE TABLET, FILM COATED [INJECTA MEDCIAL LLC]",
"spl_version": "3",
"published_date": "2026-05-28"
}
},
"productid": "69315-260_aedd35df-9c0a-4dfb-ac09-dcb63675a420",
"productndc": "69315-260",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215745",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Feb 23, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOROLAC TROMETHAMINE",
"shortage_reason": "Ketorolac Tromethamine Injection",
"shortage_status": "current",
"proprietary_name": "KETOROLAC TROMETHAMINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215745",
"marketing_category": "ANDA",
"nonproprietary_name": "KETOROLAC TROMETHAMINE",
"start_marketing_date": "20240301",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M01AB.
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