Ketorolac Tromethamine

Product NDC
55154-0120
11-digit product format
551540120
Labeler code
55154
Product ID
55154-0120_c4345cef-6211-46b5-afc2-b0a5e84f94da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA074802
Marketing category
ANDA
Marketing start
2011-07-27
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074802-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05
A074802-002KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074802-001AP
A074802-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074802-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAPRS1997-06-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A074802-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAPRS1997-06-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074802-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074802-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074802-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074802-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074802-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074802-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074802-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074802-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074802-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074802-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074802-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074802-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074802-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074802-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074802-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074802-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074802-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074802-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074802-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074802-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074802-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074802-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074802-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074802-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074802-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074802-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074802-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074802-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074802-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074802-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074802-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074802-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074802-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074802-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074802-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074802-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074802-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074802-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074802-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074802-002AP1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4EVE5946BQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860092Internal RxNorm lookup
1665461Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd489c86-08c0-4457-86f3-c4f36a70276cAvailable on FDA.report

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
55154-0120-5Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION120
55154-0120-5Ketorolac Tromethamine5 in 1 BAGINJECTION, SOLUTION520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-0120-5ML - Milliliter55154-012056829df6-84d2-4a45-9b08-ddc6480ed66912018-07-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-0120KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]20Current NDC, Legacy NDC, 2 package rows20250124_dd489c86-08c0-4457-86f3-c4f36a70276c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.8accbb78-fc64-45d5-69b0-35c23a1d2a2e2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCdd489c86-08c0-4457-86f3-c4f36a70276c2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
ndc (product): 55154-0120
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCf0cd5dfa-7eba-449f-a54a-a5155024a77e2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst3d746288-681a-5232-e063-6394a90afabd2025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.004588ba-e109-4a53-9c9d-a42dea9bb8482022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst76446045-3cca-0206-e053-2a91aa0a24402020-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074802
application number: ANDA074802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-0120-5551540120055 VIAL, SINGLE-DOSE in 1 BAG (55154-0120-5) / 1 mL in 1 VIAL, SINGLE-DOSE2011-07-270000-00-00NoNoCurrent