KETOROLAC TROMETHAMINE

Product NDC: 65145-147
11-digit product format: 651450147
Labeler code: 65145
Product ID: 65145-147_f12a602a-98ed-4ceb-bcef-f30bbd8fd7fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Caplin Steriles Limited
Application: ANDA217789
Marketing category: ANDA
Marketing start: 2024-10-04
Substance: KETOROLAC TROMETHAMINE
Active strength: 60 mg/2mL
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 43.

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
A217789-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2023-05-10
A217789-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2023-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217789-001	AP
A217789-002	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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217789-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217789-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2023-05-10	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217789-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217789-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217789-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217789-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217789-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217789-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217789-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217789-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217789-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217789-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217789-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217789-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217789-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217789-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217789-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217789-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217789-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217789-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217789-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217789-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217789-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217789-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217789-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217789-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217789-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217789-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217789-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217789-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217789-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217789-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217789-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217789-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217789-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217789-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217789-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217789-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217789-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217789-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217789-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217789-002	AP	1	`a72a2bbeb626…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOROLAC TROMETHAMINE	60 mg/2mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860092	Internal RxNorm lookup
1665459	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
588b4804-4ac5-4b96-947e-354029ea4df9	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
65145-147-01	KETOROLAC TROMETHAMINE	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		3
65145-147-25	KETOROLAC TROMETHAMINE	25 in 1 CARTON	INJECTION, SOLUTION	25		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65145-147-01	ML - Milliliter	65145-147	db0cdaff-346d-4f35-89f2-8b01cb860c01	1	2024-10-04
65145-147-25	ML - Milliliter	65145-147	d8865764-dde4-4e03-8642-8f47dd54fe7e	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65145-147	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]	3	Current NDC, 2 package rows	20241006_588b4804-4ac5-4b96-947e-354029ea4df9.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	REMEDYREPACK INC.	cdd4d548-33f8-42d6-8eae-e36aa577c050	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217789 application number: ANDA217789
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	GLENMARK PHARMACEUTICALS INC., USA	ce992bee-a9f5-48bd-a00e-513f590d69f2	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217789 application number: ANDA217789
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	46434a32-b727-0c5b-e063-6394a90a0c48	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217789 application number: ANDA217789
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	SOLA Pharmaceuticals, LLC	2301a6a2-b88a-4c0d-bb6c-ad4a8af7da39	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217789 application number: ANDA217789
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Caplin Steriles Limited	588b4804-4ac5-4b96-947e-354029ea4df9	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217789 application number: ANDA217789 ndc (product): 65145-147

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	588b4804-4ac5-4b96-947e-354029ea4df9	3
1665461	ketorolac tromethamine 30 MG in 1 ML Injection	PSN	588b4804-4ac5-4b96-947e-354029ea4df9	3
1665459	ketorolac tromethamine 60 MG in 2 ML Injection	PSN	588b4804-4ac5-4b96-947e-354029ea4df9	3
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	588b4804-4ac5-4b96-947e-354029ea4df9	3
1665461	1 ML ketorolac tromethamine 30 MG/ML Injection	SCD	588b4804-4ac5-4b96-947e-354029ea4df9	3
1665459	2 ML ketorolac tromethamine 30 MG/ML Injection	SCD	588b4804-4ac5-4b96-947e-354029ea4df9	3
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	588b4804-4ac5-4b96-947e-354029ea4df9	3
1665461	ketorolac tromethamine 30 MG per 1 ML Injection	SY	588b4804-4ac5-4b96-947e-354029ea4df9	3
1665459	ketorolac tromethamine 60 MG per 2 ML Injection	SY	588b4804-4ac5-4b96-947e-354029ea4df9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65145-147-01	65145014701	2 mL in 1 VIAL, SINGLE-DOSE	2 ml				Historical
65145-147-25	65145014725	25 VIAL, SINGLE-DOSE in 1 CARTON (65145-147-25) / 2 mL in 1 VIAL, SINGLE-DOSE (65145-147-01)		2024-10-04	No	No	Current