FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
0409-3793
11-digit product format
004093793
Labeler code
0409
Product ID
0409-3793_572e3ce2-a27c-4a65-9593-84666518ddca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA074802
Marketing category
ANDA
Marketing start
2005-06-06
Substance
KETOROLAC TROMETHAMINE
Active strength
15 mg/mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorolac Tromethamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860092, 1665459, 1665461

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3793-01Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION2535
0409-3793-19Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION135
0409-3793-25Ketorolac Tromethamine25 in 1 CARTONINJECTION, SOLUTION2535

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3793-01ML - Milliliter0409-3793c95a7159-4f72-403c-9dd5-460d9e126cc212012-07-24
0409-3793-19ML - Milliliter0409-3793c35e6706-8104-4e6c-ac26-8bd5651ddc2e12015-05-05
0409-3793-25ML - Milliliter0409-379379631abc-7549-41e4-a1d8-755347c951d112025-01-14
0409-3793-49ML - Milliliter0409-3793b29b5d12-df47-49b6-b957-cc5fdbfeee3e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.]15
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.]15
ALCOHOLINACTIVE INGREDIENT3K9958V90MKETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.]15
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.]15
WATERINACTIVE INGREDIENT059QF0KO0RKETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.]15
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]6
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]6
WATERINACTIVE INGREDIENT059QF0KO0RKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3793KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.]30Current NDC, Legacy NDC, 3 package rows20250129_8accbb78-fc64-45d5-69b0-35c23a1d2a2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY8accbb78-fc64-45d5-69b0-35c23a1d2a2e35
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSNdd489c86-08c0-4457-86f3-c4f36a70276c20
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNdd489c86-08c0-4457-86f3-c4f36a70276c20
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCDdd489c86-08c0-4457-86f3-c4f36a70276c20
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDdd489c86-08c0-4457-86f3-c4f36a70276c20
860092ketorolac tromethamine 15 MG per 1 ML InjectionSYdd489c86-08c0-4457-86f3-c4f36a70276c20
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYdd489c86-08c0-4457-86f3-c4f36a70276c20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3793-010040937930125 VIAL, SINGLE-DOSE in 1 TRAY (0409-3793-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3793-19) 2005-06-060000-00-00NoNoCurrent
0409-3793-19004093793191 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0409-3793-250040937932525 VIAL, SINGLE-DOSE in 1 CARTON (0409-3793-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3793-19) 2024-12-30NoNoHistorical