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United States · US · US:76045-104_0dab642d-7fcf-4301-8ac9-10e64a040c6b
Ketorolac Tromethamine
In shortageOrange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11760451041024 BLISTER PACK in 1 CARTON (76045-104-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A203242
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "76045-104_0dab642d-7fcf-4301-8ac9-10e64a040c6b",
"productndc": "76045-104",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "203242",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "15MG/ML",
"product_no": "001",
"approval_date": "Oct 7, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "30MG/ML",
"product_no": "002",
"approval_date": "Oct 7, 2015"
}
],
"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": "ANDA203242",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketorolac Tromethamine",
"start_marketing_date": "20151102",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code M01AB.
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