Ketorolac Tromethamine

Product NDC
55289-328
11-digit product format
552890328
Labeler code
55289
Product ID
55289-328_d9a63bfa-1135-abd2-e053-2a95a90a8176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA074761
Marketing category
ANDA
Marketing start
2013-05-16
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
55289-328-10EA - Each55289-3286a07e271-6d47-4cae-bf08-71c2e14c27bb12012-07-24
55289-328-12EA - Each55289-328ada6059d-9670-4a63-8b20-8707beaf5d3312012-07-24
55289-328-15EA - Each55289-3280e97dea8-6793-4a4e-8fd1-04acc7fe5c6012012-07-24
55289-328-20EA - Each55289-3287069fed0-5632-4dcf-a6fc-7f04cec6116b12012-07-24
55289-328-30EA - Each55289-3284e848e57-1e58-4779-94b7-a4205ae5ffa012012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-328-105528903281010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-10) 2013-05-310000-00-00NoNoCurrent
55289-328-125528903281212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-12) 2013-05-310000-00-00NoNoCurrent
55289-328-155528903281515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-15) 2013-05-310000-00-00NoNoCurrent
55289-328-205528903282020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-20) 2013-05-310000-00-00NoNoCurrent
55289-328-305528903283030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-328-30) 2013-05-310000-00-00NoNoCurrent