FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
66267-832
11-digit product format
662670832
Labeler code
66267
Product ID
66267-832_1fa76f84-21ff-0e56-e063-6394a90a1a7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
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
66267-832-042021-02-11C16284748780-1ba0f9c33-1155-a910-e053-dadaa90a0b85KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
66267-832-082021-02-11C16284748780-1ba0f9c33-1155-a910-e053-dadaa90a0b85KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
66267-832-042021-01-29C16284748780-1ba0f9c33-1155-a910-e053-dadaa90a0b85KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
66267-832-082021-01-29C16284748780-1ba0f9c33-1155-a910-e053-dadaa90a0b85KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-832-04Ketorolac Tromethamine4 in 1 BOTTLETABLET, FILM COATED46
66267-832-08Ketorolac Tromethamine8 in 1 BOTTLETABLET, FILM COATED86

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-832KETOROLAC TROMETHAMINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20240815_46dc8f62-e754-50e3-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN46dc8f62-e754-50e3-e054-00144ff8d46c6
834022ketorolac tromethamine 10 MG Oral TabletSCD46dc8f62-e754-50e3-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66267-832-04662670832044 TABLET, FILM COATED in 1 BOTTLE (66267-832-04) 2017-01-240000-00-00NoNoCurrent
66267-832-08662670832088 TABLET, FILM COATED in 1 BOTTLE (66267-832-08) 2017-01-240000-00-00NoNoCurrent