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United States · US · US:60505-1003_fb740a51-5459-3c22-949d-7e4c9142fe84
Ketorolac Tromethamine
In shortageOrange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1160505100311 BOTTLE, DROPPER in 1 CARTON (60505-1003-1) / 5 mL in 1 BOTTLE, DROPPER
- ndc1160505100321 BOTTLE, DROPPER in 1 CARTON (60505-1003-2) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A076109
AT
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": "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": "60505-1003_fb740a51-5459-3c22-949d-7e4c9142fe84",
"productndc": "60505-1003",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "076109",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Nov 5, 2009"
}
],
"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/mL",
"application_number": "ANDA076109",
"marketing_category": "ANDA",
"nonproprietary_name": "ketorolac tromethamine",
"start_marketing_date": "20091207",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M01AB.
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