Ketorolac Tromethamine

Product NDC: 55154-0120
11-digit product format: 551540120
Labeler code: 55154
Product ID: 55154-0120_d218a7a0-51b5-48b8-982f-afdc89d1ef9e
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074802-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05
A074802-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05

Therapeutic equivalence codes#

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

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

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074802-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074802-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	RS	1997-06-05	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074802-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074802-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074802-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074802-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074802-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074802-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074802-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074802-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074802-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074802-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074802-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074802-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074802-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074802-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074802-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074802-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074802-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074802-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074802-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074802-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074802-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074802-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074802-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074802-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074802-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074802-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074802-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074802-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074802-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074802-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074802-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074802-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074802-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074802-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074802-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074802-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074802-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074802-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074802-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074802-002	AP	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOROLAC TROMETHAMINE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4EVE5946BQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
dd489c86-08c0-4457-86f3-c4f36a70276c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a38bd75-79e3-96c0-1204-08a0282902ae	Product name	4	20250128
4d6e22a5-3693-6edf-0179-2ab93aecbadb	Product name	9	20240724
03452e68-2506-686e-a908-f2381c778fc6	Product name	5	20240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	Product name	1	20140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55154-0120-5	Ketorolac Tromethamine	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		20
55154-0120-5	Ketorolac Tromethamine	5 in 1 BAG	INJECTION, SOLUTION	5		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55154-0120-5	ML - Milliliter	55154-0120	56829df6-84d2-4a45-9b08-ddc6480ed669	1	2018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	6
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-0120	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]	20	Current NDC, Legacy NDC, 2 package rows	20250124_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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Hospira, Inc.	8accbb78-fc64-45d5-69b0-35c23a1d2a2e	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074802 application number: ANDA074802
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	dd489c86-08c0-4457-86f3-c4f36a70276c	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074802 application number: ANDA074802 ndc (product): 55154-0120
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	f0cd5dfa-7eba-449f-a54a-a5155024a77e	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074802 application number: ANDA074802
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	HF Acquisition Co LLC, DBA HealthFirst	3d746288-681a-5232-e063-6394a90afabd	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074802 application number: ANDA074802
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	004588ba-e109-4a53-9c9d-a42dea9bb848	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074802 application number: ANDA074802

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4EVE5946BQ	KETOROLAC TROMETHAMINE	74103-07-4	KETOROLAC TROMETHAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860092	ketorolac tromethamine 15 MG in 1 ML Injection	PSN	dd489c86-08c0-4457-86f3-c4f36a70276c	20
1665461	ketorolac tromethamine 30 MG in 1 ML Injection	PSN	dd489c86-08c0-4457-86f3-c4f36a70276c	20
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	dd489c86-08c0-4457-86f3-c4f36a70276c	20
1665461	1 ML ketorolac tromethamine 30 MG/ML Injection	SCD	dd489c86-08c0-4457-86f3-c4f36a70276c	20
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	dd489c86-08c0-4457-86f3-c4f36a70276c	20
1665461	ketorolac tromethamine 30 MG per 1 ML Injection	SY	dd489c86-08c0-4457-86f3-c4f36a70276c	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-0120-5	55154012005	5 VIAL, SINGLE-DOSE in 1 BAG (55154-0120-5) / 1 mL in 1 VIAL, SINGLE-DOSE	2011-07-27	0000-00-00	No	No	Current