KETOROLAC TROMETHAMINE

Product NDC
51662-1488
11-digit product format
516621488
Labeler code
51662
Product ID
51662-1488_9f4486dd-7633-902d-e053-2a95a90a5479
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA204216
Marketing category
ANDA
Marketing start
2020-01-11
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
60 mg/2mL
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
2021-12-31
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
51662-1488-12025-01-30C16284748780-12cef2736-ade8-d83d-e063-dadaa90ab31fKETOROLAC TROMETHAMINE INJECTION, USP 60mg/2mL (30mg/mL) 2mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1488-1KETOROLAC TROMETHAMINE2 mL in 1 VIALINJECTION, SOLUTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1488KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Legacy NDC, 1 package rows20200224_9be407ba-651f-fa23-e053-2a95a90a6cf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN9be407ba-651f-fa23-e053-2a95a90a6cf42
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD9be407ba-651f-fa23-e053-2a95a90a6cf42
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY9be407ba-651f-fa23-e053-2a95a90a6cf42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1488-1516621488012 mL in 1 VIAL (51662-1488-1) 2 ml2020-01-110000-00-00NoNoCurrent