Ketorolac Tromethamine

Product NDC
50090-7695
11-digit product format
500907695
Labeler code
50090
Product ID
50090-7695_252f3889-6ec8-479f-aa6c-78758771512a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA216651
Marketing category
ANDA
Marketing start
2022-08-25
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4EVE5946BQKETOROLAC TROMETHAMINE74103-07-4KETOROLAC TROMETHAMINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7695-05009076950020 TABLET, FILM COATED in 1 BOTTLE (50090-7695-0) 2025-10-10NoNoHistorical
50090-7695-35009076950310 TABLET, FILM COATED in 1 BOTTLE (50090-7695-3) 2025-10-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac Tromethamine Tablets, USP Rx onlyA-S Medication Solutions2025-10-14HUMAN PRESCRIPTION DRUG LABEL1