Ketorolac Tromethamine

Product NDC
68071-2443
11-digit product format
680712443
Labeler code
68071
Product ID
68071-2443_c44434f6-7325-0858-e053-2a95a90aa14a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210616
Marketing category
ANDA
Marketing start
2018-10-11
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
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
68071-2443-22023-01-30C16284748780-1f386c649-d42c-0266-e053-dadaa90a7c1aKETOROLAC TROMETHAMINE- ketorolac tromethamine tablet, film coated Cycle Pharmaceuticals Ltd. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2443-2Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2443KETOROLAC TROMETHAMINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210609_c44434f6-7326-0858-e053-2a95a90aa14a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNc44434f6-7326-0858-e053-2a95a90aa14a1
834022ketorolac tromethamine 10 MG Oral TabletSCDc44434f6-7326-0858-e053-2a95a90aa14a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2443-26807124430220 TABLET, FILM COATED in 1 BOTTLE (68071-2443-2) 2021-06-080000-00-00NoNoCurrent