FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
76045-107
11-digit product format
760450107
Labeler code
76045
Product ID
76045-107_0dab642d-7fcf-4301-8ac9-10e64a040c6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203242
Marketing category
ANDA
Marketing start
2015-11-02
Substance
KETOROLAC TROMETHAMINE
Active strength
15 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 TROMETHAMINE15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860113, 860114, 860115

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
76045-107-10Ketorolac Tromethamine24 in 1 CARTONINJECTION, SOLUTION2417
76045-107-10Ketorolac Tromethamine1 in 1 BLISTER PACKINJECTION, SOLUTION117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-107KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]17Current NDC, Legacy NDC, 2 package rows20230910_3d88cbe6-5230-47aa-80af-0c41283d1f00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860113ketorolac tromethamine 15 MG in 1 ML Prefilled SyringePSN3d88cbe6-5230-47aa-80af-0c41283d1f0017
860114ketorolac tromethamine 30 MG in 1 ML Prefilled SyringePSN3d88cbe6-5230-47aa-80af-0c41283d1f0017
860115ketorolac tromethamine 60 MG in 2 ML Prefilled SyringePSN3d88cbe6-5230-47aa-80af-0c41283d1f0017
8601131 ML ketorolac tromethamine 15 MG/ML Prefilled SyringeSCD3d88cbe6-5230-47aa-80af-0c41283d1f0017
8601141 ML ketorolac tromethamine 30 MG/ML Prefilled SyringeSCD3d88cbe6-5230-47aa-80af-0c41283d1f0017
8601152 ML ketorolac tromethamine 30 MG/ML Prefilled SyringeSCD3d88cbe6-5230-47aa-80af-0c41283d1f0017
860113ketorolac tromethamine 15 MG per 1 ML Prefilled SyringeSY3d88cbe6-5230-47aa-80af-0c41283d1f0017
860114ketorolac tromethamine 30 MG per 1 ML Prefilled SyringeSY3d88cbe6-5230-47aa-80af-0c41283d1f0017
860115ketorolac tromethamine 60 MG per 2 ML Prefilled SyringeSY3d88cbe6-5230-47aa-80af-0c41283d1f0017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76045-107-107604501071024 BLISTER PACK in 1 CARTON (76045-107-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS24 blister pack2015-11-020000-00-00NoNoCurrent