FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
64205-113
11-digit product format
642050113
Labeler code
64205
Product ID
64205-113_4ff3a93c-7273-4ad2-9e79-27c6e2542449
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ReadyMeds
Application
ANDA074761
Marketing category
ANDA
Marketing start
2013-05-16
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
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
64205-113-102019-11-27C16284748780-19855e2a2-477f-60a7-e053-dbdaa90a05bd2f4057b1-4707-4975-949e-3d62133d96f9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-113-10Ketorolac Tromethamine10 in 1 BOTTLE, PLASTICTABLET, FILM COATED105

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5
TRIACETININACTIVE INGREDIENTXHX3C3X673KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-113KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]5Legacy NDC, 1 package rows20140515_2f4057b1-4707-4975-949e-3d62133d96f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN2f4057b1-4707-4975-949e-3d62133d96f95
834022ketorolac tromethamine 10 MG Oral TabletSCD2f4057b1-4707-4975-949e-3d62133d96f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-113-106420501131010 in 1 BOTTLE, PLASTICHistorical