Ketorolac Tromethamine

Product NDC
50090-6265
11-digit product format
500906265
Labeler code
50090
Product ID
50090-6265_2f815b5d-6289-4ae2-9bea-233f88fd4a7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210616
Marketing category
ANDA
Marketing start
2022-04-15
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
50090-6265-0EA - Each50090-62656268281f-8f42-4af9-b756-7129ffd039c912023-02-06
50090-6265-3EA - Each50090-6265b3fd8655-a0ea-4e64-9159-d566ac00e1ba12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6265KETOROLAC TROMETHAMINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC20231101_de9f7f14-b912-45e6-aebb-61852c53ae58.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6265-05009062650020 TABLET, FILM COATED in 1 BOTTLE (50090-6265-0) 2022-12-120000-00-00NoNoCurrent
50090-6265-35009062650310 TABLET, FILM COATED in 1 BOTTLE (50090-6265-3) 2022-12-120000-00-00NoNoCurrent