FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
52959-512
11-digit product format
529590512
Labeler code
52959
Product ID
52959-512_8e1a80b4-ffb1-424c-b35d-4986fa74e21f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA074754
Marketing category
ANDA
Marketing start
2010-04-20
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-512-082019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-092019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-102019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-122019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-142019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-152019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-202019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-302019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-402019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-602019-11-13C16284748780-197449f38-c3ec-f6ea-e053-dbdaa90aa703KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-512-08Ketorolac Tromethamine8 in 1 BOTTLETABLET, FILM COATED81
52959-512-09Ketorolac Tromethamine9 in 1 BOTTLETABLET, FILM COATED91
52959-512-10Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED101
52959-512-12Ketorolac Tromethamine12 in 1 BOTTLETABLET, FILM COATED121
52959-512-14Ketorolac Tromethamine14 in 1 BOTTLETABLET, FILM COATED141
52959-512-15Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED151
52959-512-20Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED201
52959-512-30Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED301
52959-512-40Ketorolac Tromethamine40 in 1 BOTTLETABLET, FILM COATED401
52959-512-60Ketorolac Tromethamine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-512-08EA - Each52959-512644156d2-8b0b-4b5e-b8fd-b4d5dce0e73612012-07-24
52959-512-09EA - Each52959-5120dd2c331-9e76-4b86-b5de-1ce87b69bc9612012-07-24
52959-512-10EA - Each52959-512ccff0e7e-59b9-4378-bb33-14976f63695412012-07-24
52959-512-12EA - Each52959-512cc3e541a-8565-4705-935c-e820e8e5637212012-07-24
52959-512-14EA - Each52959-5126512bde4-16e6-4917-9e38-470d43ecbb0712012-07-24
52959-512-15EA - Each52959-5128edc5b92-715a-4974-9212-a958bdfbff1d12012-07-24
52959-512-20EA - Each52959-512e156bf95-60b9-420d-9214-6b7232dc91ec12012-07-24
52959-512-30EA - Each52959-5122be69f1b-ae1b-484d-8f71-ffe005961ada12012-07-24
52959-512-40EA - Each52959-512f978d743-2bbe-40a3-92b2-23b11c81125612012-07-24
52959-512-60EA - Each52959-51284ce86cd-c042-46de-bd17-a52fb07ab4eb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
KETOROLAC TROMETHAMINEACTIVE MOIETY4EVE5946BQKETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PKETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AKETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-512KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 10 package rows20111208_b701aef5-3f70-4bc2-abe7-7047b6a6e2a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNb701aef5-3f70-4bc2-abe7-7047b6a6e2a51
834022ketorolac tromethamine 10 MG Oral TabletSCDb701aef5-3f70-4bc2-abe7-7047b6a6e2a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-512-08529590512088 in 1 BOTTLEHistorical
52959-512-09529590512099 in 1 BOTTLEHistorical
52959-512-105295905121010 in 1 BOTTLEHistorical
52959-512-125295905121212 in 1 BOTTLEHistorical
52959-512-145295905121414 in 1 BOTTLEHistorical
52959-512-155295905121515 in 1 BOTTLEHistorical
52959-512-205295905122020 in 1 BOTTLEHistorical
52959-512-305295905123030 in 1 BOTTLEHistorical
52959-512-405295905124040 in 1 BOTTLEHistorical
52959-512-605295905126060 in 1 BOTTLEHistorical