FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
63323-162
11-digit product format
633230162
Labeler code
63323
Product ID
63323-162_2b1c6066-d9e0-40a0-ade5-776fc35a3626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075784
Marketing category
ANDA
Marketing start
2000-10-18
Substance
KETOROLAC TROMETHAMINE
Active strength
30 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 TROMETHAMINE30 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
63323-162-00Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION18
63323-162-01Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION258
63323-162-02Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION258
63323-162-03Ketorolac Tromethamine2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION28
63323-162-11Ketorolac Tromethamine1 mL in 1 VIALINJECTION, SOLUTION18
63323-162-51Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION258
63323-162-12Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION256
63323-162-14Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION256
63323-162-23Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION16
63323-162-25Ketorolac Tromethamine2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26
63323-162-16Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION255
63323-162-26Ketorolac Tromethamine25 in 1 TRAYINJECTION, SOLUTION255
63323-162-43Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION15
63323-162-45Ketorolac Tromethamine2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-162KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 6 package rows20240730_d1920335-8e45-4960-b6e9-e6f1f9e6820c.zip
63323-162KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 4 package rows20221208_950b7295-3f68-4027-ac2b-2f7d0f5f8ef9.zip
63323-162KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, Legacy NDC, 4 package rows20221117_ccf905ca-e164-4779-9485-2d139c821bad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN63b73913-246d-4e5b-bdc9-c202980d877711
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNf335a030-ffa8-4f42-8166-2f06e036b40d11
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD63b73913-246d-4e5b-bdc9-c202980d877711
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDf335a030-ffa8-4f42-8166-2f06e036b40d11
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY63b73913-246d-4e5b-bdc9-c202980d877711
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYf335a030-ffa8-4f42-8166-2f06e036b40d11
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
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNe46ebc7f-584e-e2b7-e053-2995a90ad17b2
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN9e3ddc51-b572-8fe9-e053-2995a90a2f2a2
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDe46ebc7f-584e-e2b7-e053-2995a90ad17b2
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD9e3ddc51-b572-8fe9-e053-2995a90a2f2a2
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY9e3ddc51-b572-8fe9-e053-2995a90a2f2a2
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYe46ebc7f-584e-e2b7-e053-2995a90ad17b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-162-00633230162001 mL in 1 VIAL, SINGLE-USE1 mlHistorical
63323-162-016332301620125 VIAL, SINGLE-USE in 1 TRAY (63323-162-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-162-00) 2000-10-180000-00-00NoNoCurrent
63323-162-026332301620225 VIAL, SINGLE-USE in 1 TRAY (63323-162-02) / 2 mL in 1 VIAL, SINGLE-USE (63323-162-03) 2000-10-180000-00-00NoNoCurrent
63323-162-03633230162032 mL in 1 VIAL, SINGLE-USE2 mlHistorical
63323-162-11633230162111 mL in 1 VIAL1 mlHistorical
63323-162-126332301621225 VIAL, SINGLE-DOSE in 1 TRAY (63323-162-12) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-162-23) 2000-10-180000-00-00NoNoCurrent
63323-162-146332301621425 VIAL, SINGLE-DOSE in 1 TRAY (63323-162-14) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-162-25) 2000-10-180000-00-00NoNoCurrent
63323-162-166332301621625 VIAL, SINGLE-USE in 1 TRAY (63323-162-16) / 1 mL in 1 VIAL, SINGLE-USE (63323-162-43) 2000-10-180000-00-00NoNoCurrent
63323-162-23633230162231 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-162-25633230162252 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-162-266332301622625 VIAL, SINGLE-USE in 1 TRAY (63323-162-26) / 2 mL in 1 VIAL, SINGLE-USE (63323-162-45) 2000-10-180000-00-00NoNoCurrent
63323-162-43633230162431 mL in 1 VIAL, SINGLE-USE1 mlHistorical
63323-162-45633230162452 mL in 1 VIAL, SINGLE-USE2 mlHistorical
63323-162-516332301625125 VIAL in 1 TRAY (63323-162-51) / 1 mL in 1 VIAL (63323-162-11) 25 vial2024-10-01NoNoCurrent