FDA.reportPublic FDA data

ketorolac tromethamine

Product NDC
68071-2983
11-digit product format
680712983
Labeler code
68071
Product ID
68071-2983_33a10385-9c5e-478b-e063-6294a90a1a20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA217038
Marketing category
ANDA
Marketing start
2022-11-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ketorolac tromethamine
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2983-22025-02-10C16284748780-12cef2736-90af-d83d-e063-dadaa90ab31fKetorolac Tromethamine Tablets USP, 10 mg Rx only
68071-2983-22025-01-30C16284748780-12cef2736-90af-d83d-e063-dadaa90ab31fKetorolac Tromethamine Tablets USP, 10 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2983-2ketorolac tromethamine20 in 1 BOTTLETABLET, FILM COATED203
68071-2983-8ketorolac tromethamine28 in 1 BOTTLETABLET, FILM COATED283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2983KETOROLAC TROMETHAMINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 2 package rows20250427_fe7eb195-48be-753b-e053-6294a90a8500.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNfe7eb195-48be-753b-e053-6294a90a85003
834022ketorolac tromethamine 10 MG Oral TabletSCDfe7eb195-48be-753b-e053-6294a90a85003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-2983-26807129830220 TABLET, FILM COATED in 1 BOTTLE (68071-2983-2) 2023-06-19NoNoCurrent
68071-2983-86807129830828 TABLET, FILM COATED in 1 BOTTLE (68071-2983-8) 2025-04-25NoNoCurrent