Ketorolac Tromethamine

Product NDC
68788-8149
11-digit product format
687888149
Labeler code
68788
Product ID
68788-8149_7e435e4d-cfa1-45e1-a3d4-4081a2e2f38a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA074754
Marketing category
ANDA
Marketing start
2022-03-04
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
68788-8149-2EA - Each68788-8149eef43ab5-2649-4e66-a552-2dc6ceba091912022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8149KETOROLAC TROMETHAMINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC20240606_7e435e4d-cfa1-45e1-a3d4-4081a2e2f38a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8149-268788814902100 TABLET, FILM COATED in 1 BOTTLE (68788-8149-2) 2022-03-040000-00-00NoNoCurrent