Ketorolac Tromethamine

Product NDC
72189-371
11-digit product format
721890371
Labeler code
72189
Product ID
72189-371_ea75fe43-6872-f0e9-e053-2a95a90a35fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA210616
Marketing category
ANDA
Marketing start
2022-08-10
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-371-10EA - Each72189-3716bbc2630-34d3-4b5c-93a4-1eba784eb53b12022-11-07
72189-371-15EA - Each72189-3713c9cb11d-8963-4efc-8d5c-58131d25f92e12022-09-12
72189-371-20EA - Each72189-371b96862bf-4c97-408d-8e3e-860e2af4d9a812022-09-12
72189-371-30EA - Each72189-3717988d79c-c63d-4801-8b35-4100dce4833b12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-371KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT_RX]6Legacy NDC20250123_e5e7f0cf-70ba-2247-e053-2a95a90a314d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-371-107218903711010 TABLET, FILM COATED in 1 BOTTLE (72189-371-10) 2022-08-100000-00-00NoNoCurrent
72189-371-157218903711515 TABLET, FILM COATED in 1 BOTTLE (72189-371-15) 2022-08-100000-00-00NoNoCurrent
72189-371-207218903712020 TABLET, FILM COATED in 1 BOTTLE (72189-371-20) 2022-08-100000-00-00NoNoCurrent