KETOROLAC TROMETHAMINE

Product NDC: 43066-053
11-digit product format: 430660053
Labeler code: 43066
Product ID: 43066-053_30a3ca20-8f98-478c-8a6b-aa617f0a17a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Baxter Healthcare Corporation
Application: ANDA214456
Marketing category: ANDA
Marketing start: 2026-05-19
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 42.

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
A214456-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2022-11-02
A214456-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2022-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214456-001	AP
A214456-002	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 · 52 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
2026-08-18 06:07:40	2026-07	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214456-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214456-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2022-11-02	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214456-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214456-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214456-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214456-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214456-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214456-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214456-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214456-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214456-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214456-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214456-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214456-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214456-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214456-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214456-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214456-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214456-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214456-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214456-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214456-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214456-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214456-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214456-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214456-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214456-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214456-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214456-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214456-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214456-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214456-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214456-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214456-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214456-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214456-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214456-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214456-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214456-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214456-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214456-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214456-002	AP	1	`9b2671bbb829…`

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 · 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
30a3ca20-8f98-478c-8a6b-aa617f0a17a3	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
43066-053-01	KETOROLAC TROMETHAMINE	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		1
43066-053-10	KETOROLAC TROMETHAMINE	10 in 1 CARTON	INJECTION, SOLUTION	10		1

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	3efb4f4e-b849-3bb5-e063-6394a90a5305	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Baxter Healthcare Corporation	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456 ndc (product): 43066-053
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	3321b610-1c9b-4314-adbb-a2e163234dec	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	2900e69d-29ec-210a-e063-6294a90a5008	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	29003279-8f27-bcdc-e063-6394a90aa639	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Alembic Pharmaceuticals Inc.	419cf756-3c96-4bb8-ae96-6aea5a5f3afd	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	e0065781-ea33-4662-a8b1-c936e937ac9f	2023-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214456 application number: ANDA214456

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	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1
1665461	ketorolac tromethamine 30 MG in 1 ML Injection	PSN	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1
1665459	ketorolac tromethamine 60 MG in 2 ML Injection	PSN	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1
1665461	1 ML ketorolac tromethamine 30 MG/ML Injection	SCD	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1
1665459	2 ML ketorolac tromethamine 30 MG/ML Injection	SCD	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1
1665461	ketorolac tromethamine 30 MG per 1 ML Injection	SY	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1
1665459	ketorolac tromethamine 60 MG per 2 ML Injection	SY	30a3ca20-8f98-478c-8a6b-aa617f0a17a3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43066-053-01	43066005301	2 mL in 1 VIAL, SINGLE-DOSE	2 ml				Historical
43066-053-10	43066005310	10 VIAL, SINGLE-DOSE in 1 CARTON (43066-053-10) / 2 mL in 1 VIAL, SINGLE-DOSE (43066-053-01)		2026-05-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Injection, USP	Baxter Healthcare Corporation	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	1