Ketorolac tromethamine

Product NDC
50090-5428
11-digit product format
500905428
Labeler code
50090
Product ID
50090-5428_891f69bd-d76b-434d-8e4d-500efaa97b64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA204216
Marketing category
ANDA
Marketing start
2023-06-23
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-5428-05009054280025 VIAL in 1 CARTON (50090-5428-0) / 1 mL in 1 VIAL25 vial2023-06-23NoNoHistorical
50090-5428-1500905428011 mL in 1 VIAL (50090-5428-1) 1 ml2023-06-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac tromethamineA-S Medication Solutions2025-11-12HUMAN PRESCRIPTION DRUG LABEL13
Ketorolac tromethamineA-S Medication Solutions2024-06-10HUMAN PRESCRIPTION DRUG LABEL10