Ketorolac Tromethamine

Product NDC
55154-9398
11-digit product format
551549398
Labeler code
55154
Product ID
55154-9398_3fcbb24f-cd1c-4d0b-a8cf-bf33f584da43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Cardinal Health 107, LLC
Application
ANDA075784
Marketing category
ANDA
Marketing start
2000-10-18
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 formatDescriptionMarketing startSampleExclude flagStatus
55154-9398-5551549398055 VIAL, SINGLE-DOSE in 1 BAG (55154-9398-5) / 1 mL in 1 VIAL, SINGLE-DOSE2000-10-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac Tromethamine Injection, USPCardinal Health 107, LLC2025-10-17HUMAN PRESCRIPTION DRUG LABEL11
Ketorolac Tromethamine Injection, USPCardinal Health 107, LLC2024-03-13HUMAN PRESCRIPTION DRUG LABEL10