FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
12634-809
11-digit product format
126340809
Labeler code
12634
Product ID
12634-809_69956c5a-014b-4e75-b4c1-6e51d7e80315
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca, Inc
Application
ANDA074754
Marketing category
ANDA
Marketing start
2005-10-25
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
12634-809-002020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-012020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-252020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-552020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-572020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-592020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-602020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-612020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-652020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-662020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-712020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-792020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-802020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-852020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-912020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-952020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg
12634-809-962020-01-31C16284748780-19d75b9d0-7618-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets, USP 10mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-809-00Ketorolac Tromethamine10 in 1 BOTTLETABLET102
12634-809-01Ketorolac Tromethamine100 in 1 BOTTLETABLET1002
12634-809-25Ketorolac Tromethamine25 in 1 BLISTER PACKTABLET252
12634-809-55Ketorolac Tromethamine15 in 1 BLISTER PACKTABLET152
12634-809-57Ketorolac Tromethamine20 in 1 BLISTER PACKTABLET202
12634-809-59Ketorolac Tromethamine30 in 1 BLISTER PACKTABLET302
12634-809-60Ketorolac Tromethamine60 in 1 BOTTLETABLET602
12634-809-61Ketorolac Tromethamine10 in 1 BLISTER PACKTABLET102
12634-809-65Ketorolac Tromethamine5 in 1 BLISTER PACKTABLET52
12634-809-66Ketorolac Tromethamine6 in 1 BLISTER PACKTABLET62
12634-809-71Ketorolac Tromethamine30 in 1 BOTTLETABLET302
12634-809-79Ketorolac Tromethamine25 in 1 BOTTLETABLET252
12634-809-80Ketorolac Tromethamine20 in 1 BOTTLETABLET202
12634-809-85Ketorolac Tromethamine15 in 1 BOTTLETABLET152
12634-809-91Ketorolac Tromethamine1 in 1 BLISTER PACKTABLET12
12634-809-95Ketorolac Tromethamine5 in 1 BOTTLETABLET52
12634-809-96Ketorolac Tromethamine6 in 1 BOTTLETABLET62

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-809KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]2Legacy NDC, 17 package rows20140118_e20df5b6-84da-4715-b36e-bb7e4be55416.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNe20df5b6-84da-4715-b36e-bb7e4be554162
834022ketorolac tromethamine 10 MG Oral TabletSCDe20df5b6-84da-4715-b36e-bb7e4be554162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-809-001263408090010 in 1 BOTTLEHistorical
12634-809-0112634080901100 in 1 BOTTLEHistorical
12634-809-251263408092525 in 1 BLISTER PACKHistorical
12634-809-551263408095515 in 1 BLISTER PACKHistorical
12634-809-571263408095720 in 1 BLISTER PACKHistorical
12634-809-591263408095930 in 1 BLISTER PACKHistorical
12634-809-601263408096060 in 1 BOTTLEHistorical
12634-809-611263408096110 in 1 BLISTER PACKHistorical
12634-809-65126340809655 in 1 BLISTER PACKHistorical
12634-809-66126340809666 in 1 BLISTER PACKHistorical
12634-809-711263408097130 in 1 BOTTLEHistorical
12634-809-791263408097925 in 1 BOTTLEHistorical
12634-809-801263408098020 in 1 BOTTLEHistorical
12634-809-851263408098515 in 1 BOTTLEHistorical
12634-809-91126340809911 in 1 BLISTER PACKHistorical
12634-809-95126340809955 in 1 BOTTLEHistorical
12634-809-96126340809966 in 1 BOTTLEHistorical