FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
63323-161
11-digit product format
633230161
Labeler code
63323
Product ID
63323-161_2b1c6066-d9e0-40a0-ade5-776fc35a3626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075784
Marketing category
ANDA
Marketing start
2001-09-05
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
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 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
63323-161-00Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION18
63323-161-01Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION258
63323-161-12Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION256
63323-161-21Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION16
63323-161-16Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION255
63323-161-41Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-161-00ML - Milliliter63323-16161dcf0f8-fd19-497d-9277-b6447e4192a712022-05-04
63323-161-01ML - Milliliter63323-161ac8552e4-7cfd-461a-880d-7b7d6c8a66e312013-02-13
63323-161-12ML - Milliliter63323-16171f9d249-0b8f-410c-aaaa-c25d55483ed112015-03-03
63323-161-16ML - Milliliter63323-161f17ba35e-5041-4395-a4ab-3c9153216ff012015-12-02
63323-161-21ML - Milliliter63323-161fc69bd60-df92-422a-a9b2-bde63582336a12022-05-04
63323-161-41ML - Milliliter63323-161e74ed780-a563-41d0-83b3-a2062667293212022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-161KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 2 package rows20240730_d1920335-8e45-4960-b6e9-e6f1f9e6820c.zip
63323-161KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20221208_950b7295-3f68-4027-ac2b-2f7d0f5f8ef9.zip
63323-161KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, Legacy NDC, 2 package rows20221117_ccf905ca-e164-4779-9485-2d139c821bad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN6758cb38-dec8-468f-94e2-613772e39b9a9
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD6758cb38-dec8-468f-94e2-613772e39b9a9
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY6758cb38-dec8-468f-94e2-613772e39b9a9
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSNd1920335-8e45-4960-b6e9-e6f1f9e6820c8
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNd1920335-8e45-4960-b6e9-e6f1f9e6820c8
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSNd1920335-8e45-4960-b6e9-e6f1f9e6820c8
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCDd1920335-8e45-4960-b6e9-e6f1f9e6820c8
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDd1920335-8e45-4960-b6e9-e6f1f9e6820c8
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCDd1920335-8e45-4960-b6e9-e6f1f9e6820c8
860092ketorolac tromethamine 15 MG per 1 ML InjectionSYd1920335-8e45-4960-b6e9-e6f1f9e6820c8
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYd1920335-8e45-4960-b6e9-e6f1f9e6820c8
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSYd1920335-8e45-4960-b6e9-e6f1f9e6820c8
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY950b7295-3f68-4027-ac2b-2f7d0f5f8ef96
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSNccf905ca-e164-4779-9485-2d139c821bad5
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNccf905ca-e164-4779-9485-2d139c821bad5
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSNccf905ca-e164-4779-9485-2d139c821bad5
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCDccf905ca-e164-4779-9485-2d139c821bad5
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDccf905ca-e164-4779-9485-2d139c821bad5
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCDccf905ca-e164-4779-9485-2d139c821bad5
860092ketorolac tromethamine 15 MG per 1 ML InjectionSYccf905ca-e164-4779-9485-2d139c821bad5
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYccf905ca-e164-4779-9485-2d139c821bad5
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSYccf905ca-e164-4779-9485-2d139c821bad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-161-00633230161001 mL in 1 VIAL, SINGLE-USE1 mlHistorical
63323-161-016332301610125 VIAL, SINGLE-USE in 1 TRAY (63323-161-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-161-00) 2001-09-050000-00-00NoNoCurrent
63323-161-126332301611225 VIAL, SINGLE-DOSE in 1 TRAY (63323-161-12) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-161-21) 2001-09-050000-00-00NoNoCurrent
63323-161-166332301611625 VIAL, SINGLE-USE in 1 TRAY (63323-161-16) / 1 mL in 1 VIAL, SINGLE-USE (63323-161-41) 2001-09-050000-00-00NoNoCurrent
63323-161-21633230161211 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-161-41633230161411 mL in 1 VIAL, SINGLE-USE1 mlHistorical