Ketorolac Tromethamine

Product NDC
45865-657
11-digit product format
458650657
Labeler code
45865
Product ID
45865-657_720592fe-37b1-75c1-e053-2a95a90af983
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyMedsource Pharmaceuticals2018-07-27HUMAN PRESCRIPTION DRUG LABEL1