Ketorolac Tromethamine

Product NDC
80425-0139
11-digit product format
804250139
Labeler code
80425
Product ID
80425-0139_2a99c981-daeb-71e5-e063-6294a90a5c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
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
80425-0139-18042501390130 TABLET, FILM COATED in 1 BOTTLE (80425-0139-1) 1998-06-17NoNoHistorical
80425-0139-2804250139029 TABLET, FILM COATED in 1 BOTTLE (80425-0139-2) 1998-06-17NoNoHistorical
80425-0139-38042501390320 TABLET, FILM COATED in 1 BOTTLE (80425-0139-3) 1998-06-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac Tromethamine TabletAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL5
Ketorolac Tromethamine 10mg TabletAdvanced Rx Pharmacy of Tennessee, LLC2022-11-10HUMAN PRESCRIPTION DRUG LABEL4