Ketorolac tromethamine

Product NDC
76420-272
11-digit product format
764200272
Labeler code
76420
Product ID
76420-272_e7aa72fc-eb56-e9e2-e053-2a95a90a2df2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Asclemed USA, Inc.
Application
ANDA204216
Marketing category
ANDA
Marketing start
2019-03-18
Substance
KETOROLAC TROMETHAMINE
Active strength
60 mg/2mL
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
76420-272-02764200272022 mL in 1 VIAL (76420-272-02) 2 ml2022-09-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac Tromethamine Injection, USP Rx only FOR INTRAMUSCULAR USE ONLY (60 mg)Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2022-09-01HUMAN PRESCRIPTION DRUG LABEL1