FDA.reportPublic FDA data

KETOROLAC TROMETHAMINE

Product NDC
65145-147
11-digit product format
651450147
Labeler code
65145
Product ID
65145-147_f12a602a-98ed-4ceb-bcef-f30bbd8fd7fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Caplin Steriles Limited
Application
ANDA217789
Marketing category
ANDA
Marketing start
2024-10-04
Substance
KETOROLAC TROMETHAMINE
Active strength
60 mg/2mL
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 TROMETHAMINE60 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860092, 1665459, 1665461

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
65145-147-01KETOROLAC TROMETHAMINE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION23
65145-147-25KETOROLAC TROMETHAMINE25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-147-01ML - Milliliter65145-147db0cdaff-346d-4f35-89f2-8b01cb860c0112024-10-04
65145-147-25ML - Milliliter65145-147d8865764-dde4-4e03-8642-8f47dd54fe7e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-147KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]3Current NDC, 2 package rows20241006_588b4804-4ac5-4b96-947e-354029ea4df9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN588b4804-4ac5-4b96-947e-354029ea4df93
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN588b4804-4ac5-4b96-947e-354029ea4df93
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN588b4804-4ac5-4b96-947e-354029ea4df93
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD588b4804-4ac5-4b96-947e-354029ea4df93
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD588b4804-4ac5-4b96-947e-354029ea4df93
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD588b4804-4ac5-4b96-947e-354029ea4df93
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY588b4804-4ac5-4b96-947e-354029ea4df93
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY588b4804-4ac5-4b96-947e-354029ea4df93
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY588b4804-4ac5-4b96-947e-354029ea4df93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-147-01651450147012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
65145-147-256514501472525 VIAL, SINGLE-DOSE in 1 CARTON (65145-147-25) / 2 mL in 1 VIAL, SINGLE-DOSE (65145-147-01) 2024-10-04NoNoCurrent