Ketorolac Tromethamine

Product NDC: 50090-3397
11-digit product format: 500903397
Labeler code: 50090
Product ID: 50090-3397_a87a8ce5-6f1b-453c-8b72-dc1aa2aedaf8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: A-S Medication Solutions
Application: ANDA204216
Marketing category: ANDA
Marketing start: 2017-09-29
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 30 mg/mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-3397		I	Inactivated by FDA		2026-08-17
excluded package	package	50090-3397	50090-3397-1	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3397-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3397-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3397-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3397-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3397-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3397-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3397-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3397-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3397-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3397-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3397-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-3397-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-3397-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-3397-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-3397-1	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 84 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	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A204216-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204216-002	AP	1	`caaa826d4ba7…`
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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3397-1	2023-01-30	C162847	48780-1	f386c64a-2228-0266-e053-dadaa90a7c1a	Ketorolac Tromethamine Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3397-1	Ketorolac Tromethamine	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		1
50090-3397-1	Ketorolac Tromethamine	25 in 1 CARTON	INJECTION, SOLUTION	25		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3397-1	ML - Milliliter	50090-3397	fbfef85c-2a4b-473b-b9ee-0c796824e9cc	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3397	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 2 package rows	20190205_6dd21587-12ce-4f43-9761-43bc73d96906.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
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
1665459	ketorolac tromethamine 60 MG in 2 ML Injection	PSN	6dd21587-12ce-4f43-9761-43bc73d96906	1
1665459	2 ML ketorolac tromethamine 30 MG/ML Injection	SCD	6dd21587-12ce-4f43-9761-43bc73d96906	1
1665459	ketorolac tromethamine 60 MG per 2 ML Injection	SY	6dd21587-12ce-4f43-9761-43bc73d96906	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3397-1	50090339701	25 VIAL, SINGLE-DOSE in 1 CARTON (50090-3397-1) > 2 mL in 1 VIAL, SINGLE-DOSE	2018-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Injection, USP	A-S Medication Solutions	2018-10-09	HUMAN PRESCRIPTION DRUG LABEL	1