ketorolac tromethamine

Product NDC: 72266-234
11-digit product format: 722660234
Labeler code: 72266
Product ID: 72266-234_228ec94a-f777-f61b-e063-6394a90a21a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: FOSUN PHARMA USA INC
Application: ANDA204216
Marketing category: ANDA
Marketing start: 2023-06-23
Substance: KETOROLAC TROMETHAMINE
Active strength: 15 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204216-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2016-11-01
A204216-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2016-11-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204216-001	AP
A204216-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204216-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204216-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204216-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204216-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204216-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204216-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204216-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204216-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204216-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204216-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204216-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204216-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204216-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204216-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204216-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204216-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204216-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204216-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204216-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204216-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204216-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204216-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204216-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204216-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204216-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204216-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204216-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204216-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204216-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204216-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204216-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204216-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204216-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204216-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204216-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204216-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204216-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204216-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204216-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204216-002	AP	1	`782e0a99824c…`

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	15 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
1aae6a4d-0909-4672-aa26-e3f2d8c4d413	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72266-234-01	ketorolac tromethamine	1 mL in 1 VIAL	INJECTION, SOLUTION	1		16
72266-234-25	ketorolac tromethamine	25 in 1 CARTON	INJECTION, SOLUTION	25		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72266-234-01	ML - Milliliter	72266-234	78068ba0-2d94-4cf3-bbb3-20d47c724724	1	2023-08-08
72266-234-25	ML - Milliliter	72266-234	ade24dfc-882f-4113-a6e0-1fee2128d17e	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72266-234	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FOSUN PHARMA USA INC]	16	Current NDC, 2 package rows	20250306_1aae6a4d-0909-4672-aa26-e3f2d8c4d413.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	26a1761b-90bf-49c6-9e6a-f293af2296ce	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Direct_rx	22de8e1c-5e68-fd78-e063-6394a90ad40b	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	43d07956-90ba-4e96-b265-aec03eced19b	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	2a23b0fa-803c-4abb-b588-12cfe83326a9	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Civica, Inc.	32198544-4a46-495c-ab65-0836dcbc2c49	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
ketorolac tromethamine	KETOROLAC TROMETHAMINE	ProPharma Distribution	42dfd39e-53a3-e9ee-e063-6394a90ab51e	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	5e42914f-de71-4176-819b-9fa26a8bdce6	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sagent Pharmaceuticals	62591551-a644-4b2c-a0de-982e906fabc3	2025-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	ProPharma Distribution	3f2956d9-9e68-f35e-e063-6394a90a706d	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	99c06dde-f218-4d81-91e0-f37a748872d6	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	1e65d11b-5aa9-4a6b-b5d6-c19828748fea	2025-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	606b0f2f-de28-42a9-96f4-cacba2c7c56a	2025-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	6f727e1f-2838-427b-a236-eeb0101b08f3	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
ketorolac tromethamine	KETOROLAC TROMETHAMINE	FOSUN PHARMA USA INC	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	2024-09-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216 ndc (product): 72266-234
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Gland Pharma Limited	5abd4389-4fb2-408b-a27e-cf64b6a921f1	2024-09-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	ada639d4-babb-2ad0-e053-2a95a90afce7	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	e17f583d-8bd4-3ed0-e053-2a95a90a9090	2023-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	b88e562d-226b-4200-afa5-034e628c660f	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	ee44c322-4b4b-4397-a1a5-e5b3c3c5a053	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	014ba8d7-7ed3-4d4a-847a-22b65161117e	2021-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216

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	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
1665461	ketorolac tromethamine 30 MG in 1 ML Injection	PSN	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
1665459	ketorolac tromethamine 60 MG in 2 ML Injection	PSN	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
1665461	1 ML ketorolac tromethamine 30 MG/ML Injection	SCD	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
1665459	2 ML ketorolac tromethamine 30 MG/ML Injection	SCD	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
1665461	ketorolac tromethamine 30 MG per 1 ML Injection	SY	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
1665459	ketorolac tromethamine 60 MG per 2 ML Injection	SY	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	16
860092	ketorolac tromethamine 15 MG in 1 ML Injection	PSN	1e65d11b-5aa9-4a6b-b5d6-c19828748fea	2
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	1e65d11b-5aa9-4a6b-b5d6-c19828748fea	2
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	1e65d11b-5aa9-4a6b-b5d6-c19828748fea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72266-234-01	72266023401	1 mL in 1 VIAL	1 ml				Historical
72266-234-25	72266023425	25 VIAL in 1 CARTON (72266-234-25) / 1 mL in 1 VIAL (72266-234-01)	25 vial	2023-06-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine	Henry Schein, Inc.	2025-06-20	HUMAN PRESCRIPTION DRUG LABEL	2
ketorolac tromethamine	FOSUN PHARMA USA INC	2024-09-20	HUMAN PRESCRIPTION DRUG LABEL	17