Ketorolac Tromethamine

Product NDC
60687-104
11-digit product format
606870104
Labeler code
60687
Product ID
60687-104_3d6fc385-f5d1-ff60-e063-6394a90aadc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA074754
Marketing category
ANDA
Marketing start
2021-03-23
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorolac Tromethamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui834022

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-104-11Ketorolac Tromethamine1 in 1 BLISTER PACKTABLET, FILM COATED14
60687-104-21Ketorolac Tromethamine30 in 1 BOX, UNIT-DOSETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-104KETOROLAC TROMETHAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20241017_48244614-53ec-47e6-ad48-50814bdcceb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN48244614-53ec-47e6-ad48-50814bdcceb74
834022ketorolac tromethamine 10 MG Oral TabletSCD48244614-53ec-47e6-ad48-50814bdcceb74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-104-11606870104111 in 1 BLISTER PACKHistorical
60687-104-216068701042130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-104-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-104-11) 30 blister pack2021-03-230000-00-00NoNoCurrent