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United States · US · US:0378-1134_a2e96323-5726-45ce-9e73-f143f122b06b
Ketorolac Tromethamine
In shortageOrange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110378113401100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1134-01)
Annotations
UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A074761
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": "0378-1134_a2e96323-5726-45ce-9e73-f143f122b06b",
"productndc": "0378-1134",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "074761",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 16, 1997"
}
],
"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": "ANDA074761",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketorolac Tromethamine",
"start_marketing_date": "20130516",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M01AB.
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