Ketorolac Tromethamine

Product NDC
35573-450
11-digit product format
355730450
Labeler code
35573
Product ID
35573-450_10f6d6b7-63cf-4980-8a8d-b8be6c37e203
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA210616
Marketing category
ANDA
Marketing start
2022-04-15
Marketing end
0000-00-00
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
2023-12-31
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
35573-450-02EA - Each35573-450d084049f-5a22-4967-8c14-cf94cece197912022-05-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN1d8b4f77-8a6a-6bac-e063-6294a90ae8181
834022ketorolac tromethamine 10 MG Oral TabletSCD1d8b4f77-8a6a-6bac-e063-6294a90ae8181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35573-450-0235573045002100 TABLET, FILM COATED in 1 BOTTLE (35573-450-02) 2022-04-150000-00-00NoNoCurrent