FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
50090-5609
11-digit product format
500905609
Labeler code
50090
Product ID
50090-5609_dd320e54-f40e-4419-9ed4-2b4e485a56f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA204216
Marketing category
ANDA
Marketing start
2020-02-01
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
Rxcui860092

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5609-02023-02-07C16284748780-1f386c649-9c1e-0266-e053-dadaa90a7c1aKetorolac Tromethamine Injection, USP
50090-5609-02023-01-30C16284748780-1f386c649-9c1e-0266-e053-dadaa90a7c1aKetorolac Tromethamine Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5609-0Ketorolac Tromethamine25 in 1 CARTONINJECTION, SOLUTION253
50090-5609-0Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5609KETOROLAC TROMETHAMINE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230208_b88e562d-226b-4200-afa5-034e628c660f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSNb88e562d-226b-4200-afa5-034e628c660f3
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCDb88e562d-226b-4200-afa5-034e628c660f3
860092ketorolac tromethamine 15 MG per 1 ML InjectionSYb88e562d-226b-4200-afa5-034e628c660f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5609-05009056090025 VIAL, SINGLE-DOSE in 1 CARTON (50090-5609-0) / 1 mL in 1 VIAL, SINGLE-DOSE2021-08-040000-00-00NoNoCurrent