Ketorolac Tromethamine

Product NDC
69543-388
11-digit product format
695430388
Labeler code
69543
Product ID
69543-388_7a8ad75f-f969-495b-bc73-f8fb86085b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Virtus Pharmaceuticals, LLC
Application
ANDA210616
Marketing category
ANDA
Marketing start
2018-10-11
Marketing end
2024-09-30
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-388-10EA - Each69543-3888c2119e5-407c-44c9-b1cb-e5dfaba1a90e12018-11-06

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
69543-388-1069543038810100 TABLET, FILM COATED in 1 BOTTLE (69543-388-10) 2018-10-110000-00-00NoNoCurrent