FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
63629-2974
11-digit product format
636292974
Labeler code
63629
Product ID
63629-2974_1d9caf46-330d-433f-962e-8da0468be79e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-2974-02020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-12020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-22020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-32020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-42020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-52020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-62020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-72020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-82020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-92020-02-25C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-02020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-12020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-22020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-32020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-42020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-52020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-62020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-72020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-82020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-92020-01-31C16284748780-19d75b9d0-29d1-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2974-0Ketorolac Tromethamine3 in 1 BOTTLETABLET, FILM COATED39
63629-2974-1Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED309
63629-2974-2Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED109
63629-2974-3Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED209
63629-2974-4Ketorolac Tromethamine90 in 1 BOTTLETABLET, FILM COATED909
63629-2974-5Ketorolac Tromethamine16 in 1 BOTTLETABLET, FILM COATED169
63629-2974-6Ketorolac Tromethamine8 in 1 BOTTLETABLET, FILM COATED89
63629-2974-7Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED159
63629-2974-8Ketorolac Tromethamine5 in 1 BOTTLETABLET, FILM COATED59
63629-2974-9Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2974-1EA - Each63629-29746397c33a-5a04-4871-be93-21b6c5a053fa12012-07-24
63629-2974-2EA - Each63629-29742cd49b80-261e-4664-89ee-f858377795c412012-07-24
63629-2974-3EA - Each63629-2974216e37ae-185a-46a9-8a0d-4a771cabef6712012-07-24
63629-2974-4EA - Each63629-2974344b0a89-4921-4423-af5b-e02367b8a89c12012-07-24
63629-2974-5EA - Each63629-2974567ce373-8e35-4c37-b0bb-9d25adcd444712012-07-24
63629-2974-6EA - Each63629-2974cbb255f1-f663-4a34-90c7-4e042526b0b012012-07-24
63629-2974-7EA - Each63629-29740f42e9c0-81ce-4017-9416-058cc29bb85712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2974KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 10 package rows20231129_f713500a-20b8-8e20-c4cc-956805170335.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNf713500a-20b8-8e20-c4cc-9568051703359
834022ketorolac tromethamine 10 MG Oral TabletSCDf713500a-20b8-8e20-c4cc-9568051703359

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2974-0636292974003 TABLET, FILM COATED in 1 BOTTLE (63629-2974-0) 2011-05-090000-00-00NoNoCurrent
63629-2974-16362929740130 TABLET, FILM COATED in 1 BOTTLE (63629-2974-1) 2009-04-030000-00-00NoNoCurrent
63629-2974-26362929740210 TABLET, FILM COATED in 1 BOTTLE (63629-2974-2) 2006-03-090000-00-00NoNoCurrent
63629-2974-36362929740320 TABLET, FILM COATED in 1 BOTTLE (63629-2974-3) 2009-04-030000-00-00NoNoCurrent
63629-2974-46362929740490 TABLET, FILM COATED in 1 BOTTLE (63629-2974-4) 2014-10-090000-00-00NoNoCurrent
63629-2974-56362929740516 TABLET, FILM COATED in 1 BOTTLE (63629-2974-5) 2012-03-230000-00-00NoNoCurrent
63629-2974-6636292974068 TABLET, FILM COATED in 1 BOTTLE (63629-2974-6) 2014-03-310000-00-00NoNoCurrent
63629-2974-76362929740715 TABLET, FILM COATED in 1 BOTTLE (63629-2974-7) 2010-02-110000-00-00NoNoCurrent
63629-2974-8636292974085 TABLET, FILM COATED in 1 BOTTLE (63629-2974-8) 2011-04-110000-00-00NoNoCurrent
63629-2974-963629297409100 TABLET, FILM COATED in 1 BOTTLE (63629-2974-9) 2021-12-220000-00-00NoNoCurrent