Ketorolac Tromethamine

Product NDC
70934-029
11-digit product format
709340029
Labeler code
70934
Product ID
70934-029_b7b0806f-995d-1d60-e053-2a95a90a9b59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA074754
Marketing category
ANDA
Marketing start
2017-03-17
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-029-15Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED156
70934-029-20Ketorolac Tromethamine20 in 1 BOTTLE, PLASTICTABLET, FILM COATED206
70934-029-30Ketorolac Tromethamine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-029-15EA - Each70934-02990248741-173f-4a13-977a-469c5c5d5d7212018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-029KETOROLAC TROMETHAMINE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]6Legacy NDC, 3 package rows20201231_4af70eae-71ca-65f2-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN4af70eae-71ca-65f2-e054-00144ff88e886
834022ketorolac tromethamine 10 MG Oral TabletSCD4af70eae-71ca-65f2-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-029-157093400291515 TABLET, FILM COATED in 1 BOTTLE (70934-029-15) 2017-03-170000-00-00NoNoCurrent
70934-029-207093400292020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-029-20) 2018-11-190000-00-00NoNoCurrent
70934-029-307093400293030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-029-30) 2018-10-290000-00-00NoNoCurrent