🇺🇸
United States · US · US:68788-8549_188e7fb8-ec35-43ed-a35a-a4a19a04b7c1
Ketorolac Tromethamine
In shortageOrange BookUNIISPLATC M01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168788854955 mL in 1 BOTTLE (68788-8549-5)
Annotations
UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A203410
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": "68788-8549_188e7fb8-ec35-43ed-a35a-a4a19a04b7c1",
"productndc": "68788-8549",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "203410",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Apr 5, 2019"
}
],
"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": "ANDA203410",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketorolac Tromethamine",
"start_marketing_date": "20231115",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M01AB.
Access this data programmatically
Query Ketorolac Tromethamine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.