Ketorolac Tromethamine

Product NDC: 68788-9321
11-digit product format: 687889321
Labeler code: 68788
Product ID: 68788-9321_1f8b8fa6-a531-4d75-a217-45b68052a32d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA078434
Marketing category: ANDA
Marketing start: 2015-04-13
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 5 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: 2019-12-31
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	68788-9321		D	Discontinued by firm		2026-08-17
excluded package	package	68788-9321	68788-9321-5	D	Discontinued by firm		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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9321-5	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9321-5	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9321-5	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9321-5	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9321-5	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9321-5	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9321-5	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9321-5	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9321-5	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9321-5	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9321-5	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9321-5	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68788-9321-5	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078434-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC			2009-11-05

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 · 42 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	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078434-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078434-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078434-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078434-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078434-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078434-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078434-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078434-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078434-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078434-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078434-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078434-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078434-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078434-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A078434-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078434-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078434-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078434-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078434-001	AT	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68788-9321-5	2020-11-12	C162847	48780-1	9d75b9d1-1308-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991
68788-9321-5	2020-01-31	C162847	48780-1	9d75b9d1-1308-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ketorolac tromethamine	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
ketorolac	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
octoxynol-40	INACTIVE INGREDIENT	9T1C662FKS	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	c2290fd1-2985-1275-e053-2995a90ad5fa	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078434 application number: ANDA078434
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	fc8ba956-4d3d-4f52-ac8e-89d52a480b48	2021-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078434 application number: ANDA078434

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine	Preferred Pharmaceuticals, Inc.	2018-08-21	HUMAN PRESCRIPTION DRUG LABEL	4