FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
10544-222
11-digit product format
105440222
Labeler code
10544
Product ID
10544-222_17c86caa-1c3f-5c6c-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA074754
Marketing category
ANDA
Marketing start
2011-07-15
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
10544-222-102020-01-31C16284748780-19d75b9d1-2073-f424-e053-dadaa90a57ceKETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
10544-222-152020-01-31C16284748780-19d75b9d1-2073-f424-e053-dadaa90a57ceKETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
10544-222-302020-01-31C16284748780-19d75b9d1-2073-f424-e053-dadaa90a57ceKETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-222-10Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED102
10544-222-15Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED152
10544-222-30Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-222-10EA - Each10544-22270fe62b8-1fc1-417d-bb13-6f5af265188d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PKETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AKETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-222KETOROLAC TROMETHAMINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 3 package rows20150605_1191f151-ab29-1f7e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN1191f151-ab29-1f7e-e054-00144ff88e882
834022ketorolac tromethamine 10 MG Oral TabletSCD1191f151-ab29-1f7e-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-222-101054402221010 in 1 BOTTLEHistorical
10544-222-151054402221515 in 1 BOTTLEHistorical
10544-222-301054402223030 in 1 BOTTLEHistorical