Ketorolac Tromethamine

Product NDC
50090-4583
11-digit product format
500904583
Labeler code
50090
Product ID
50090-4583_d9047fa6-c0e3-4ab6-9860-d6eef72911a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
ANDA075772
Marketing category
ANDA
Marketing start
2004-07-21
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-4583-02023-01-30C16284748780-1f386c64a-2798-0266-e053-dadaa90a7c1aKetorolac Tromethamine Injection, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4583-0Ketorolac Tromethamine25 in 1 CARTONINJECTION254
50090-4583-0Ketorolac Tromethamine2 mL in 1 VIALINJECTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4583KETOROLAC TROMETHAMINE INJECTION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20210615_c0d61da5-0950-4eb2-a48c-081e90069ccd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSNc0d61da5-0950-4eb2-a48c-081e90069ccd4
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCDc0d61da5-0950-4eb2-a48c-081e90069ccd4
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSYc0d61da5-0950-4eb2-a48c-081e90069ccd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4583-05009045830025 VIAL in 1 CARTON (50090-4583-0) > 2 mL in 1 VIAL25 vial2019-10-070000-00-00NoNoCurrent