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United States · US · US:69315-322_11be552b-2427-4cd7-a81d-f0ae5063d3f6
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 · 3
- ndc1169315322031 BOTTLE, DROPPER in 1 CARTON (69315-322-03) / 3 mL in 1 BOTTLE, DROPPER
- ndc1169315322051 BOTTLE, DROPPER in 1 CARTON (69315-322-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1169315322101 BOTTLE, DROPPER in 1 CARTON (69315-322-10) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A218204
AT
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": "OPHTHALMIC",
"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": "69315-322_11be552b-2427-4cd7-a81d-f0ae5063d3f6",
"productndc": "69315-322",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "218204",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Mar 26, 2024"
}
],
"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/mL",
"application_number": "ANDA218204",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketorolac Tromethamine",
"start_marketing_date": "20240601",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M01AB.
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