Ketorolac Tromethamine

Product NDC
55154-9398
11-digit product format
551549398
Labeler code
55154
Product ID
55154-9398_3fcbb24f-cd1c-4d0b-a8cf-bf33f584da43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Cardinal Health 107, LLC
Application
ANDA075784
Marketing category
ANDA
Marketing start
2000-10-18
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
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 TROMETHAMINE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui1665461

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
55154-9398-5Ketorolac Tromethamine5 in 1 BAGINJECTION, SOLUTION511
55154-9398-5Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-9398-5ML - Milliliter55154-9398866611a4-8278-44c4-b45d-4c61cd8895d712020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9398KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]10Current NDC, Legacy NDC, 2 package rows20240316_63b73913-246d-4e5b-bdc9-c202980d8777.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN63b73913-246d-4e5b-bdc9-c202980d877711
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD63b73913-246d-4e5b-bdc9-c202980d877711
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY63b73913-246d-4e5b-bdc9-c202980d877711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-9398-5551549398055 VIAL, SINGLE-DOSE in 1 BAG (55154-9398-5) / 1 mL in 1 VIAL, SINGLE-DOSE2000-10-180000-00-00NoNoCurrent