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United States · US · US:72789-437_3a25208f-aeec-f466-e063-6294a90a92ad
KETOROLAC TROMETHAMINE
In shortageOrange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117278943701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-01)
- ndc11727894371010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-10)
- ndc11727894372020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-20)
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 Tablet
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": "72789-437_3a25208f-aeec-f466-e063-6294a90a92ad",
"productndc": "72789-437",
"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 Tablet",
"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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