FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
70518-0048
11-digit product format
705180048
Labeler code
70518
Product ID
70518-0048_4cd57473-e5d5-6fd7-e063-6394a90a19ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA074754
Marketing category
ANDA
Marketing start
2016-12-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorolac Tromethamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui834022

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0048-0Ketorolac Tromethamine25 in 1 BOTTLETABLET, FILM COATED2525
70518-0048-1Ketorolac Tromethamine1 in 1 BOTTLE, PLASTICTABLET, FILM COATED125
70518-0048-2Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED10025
70518-0048-3Ketorolac Tromethamine8 in 1 BOTTLE, PLASTICTABLET, FILM COATED825
70518-0048-4Ketorolac Tromethamine20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2025
70518-0048-5Ketorolac Tromethamine10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1025
70518-0048-6Ketorolac Tromethamine12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1225

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0048KETOROLAC TROMETHAMINE TABLET, FILM COATED [REMEDYREPACK INC.]20Current NDC, Legacy NDC, 7 package rows20250529_f47d4365-40a8-445b-99cd-49edad6a8ffc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNf47d4365-40a8-445b-99cd-49edad6a8ffc25
834022ketorolac tromethamine 10 MG Oral TabletSCDf47d4365-40a8-445b-99cd-49edad6a8ffc25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0048-07051800480025 TABLET, FILM COATED in 1 BOTTLE (70518-0048-0) 2016-12-090000-00-00NoNoCurrent
70518-0048-1705180048011 in 1 BOTTLE, PLASTICHistorical
70518-0048-270518004802100 TABLET, FILM COATED in 1 BOTTLE (70518-0048-2) 2020-08-030000-00-00NoNoCurrent
70518-0048-3705180048038 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0048-3) 2020-10-210000-00-00NoNoCurrent
70518-0048-47051800480420 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0048-4) 2021-09-290000-00-00NoNoCurrent
70518-0048-57051800480510 in 1 BOTTLE, PLASTICHistorical
70518-0048-67051800480612 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0048-6) 2025-11-19NoNoHistorical