KETOROLAC TROMETHAMINE

Product NDC: 72189-054
Requested package NDC: 72189-054-05
11-digit product format: 721890054
Labeler code: 72189
Product ID: 72189-054_9624d675-0b80-8630-e053-2a95a90a2fd0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: KETOROLAC TROMETHAMINE
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: DIRECT RX
Application: ANDA076109
Marketing category: ANDA
Marketing start: 2019-10-30
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72189-054	72189-054-05	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 · 15 matching rows.

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

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

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
A076109-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2009-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076109-001	AT

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	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076109-001	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	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076109-001	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	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076109-001	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	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076109-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A076109-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076109-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076109-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076109-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076109-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076109-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076109-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076109-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076109-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076109-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076109-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076109-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076109-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076109-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076109-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076109-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076109-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076109-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076109-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076109-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076109-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076109-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076109-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076109-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076109-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076109-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076109-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076109-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076109-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076109-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076109-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076109-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076109-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076109-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076109-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076109-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076109-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076109-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076109-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076109-001	AT	1	`e64feba35796…`

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
72189-054-05	2023-01-30	C162847	48780-1	f386c649-c1d4-0266-e053-dadaa90a7c1a	KETOROLAC TROMETHAMINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-054-05	KETOROLAC TROMETHAMINE	1 mL in 1 BOTTLE	SOLUTION/ DROPS	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-054-05	ML - Milliliter	72189-054	5493486a-1bf1-423b-91ae-8bc2cc5d46c9	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-054	KETOROLAC TROMETHAMINE SOLUTION/ DROPS [DIRECT RX]	1	Legacy NDC, 1 package rows	20191123_9624d675-0b7f-8630-e053-2a95a90a2fd0.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Apotex Corp.	d9a186ba-74a9-b6d4-1109-1e045ba1763e	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076109 application number: ANDA076109
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	3b3cc67c-e1ff-3a0a-e063-6394a90adb9a	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076109 application number: ANDA076109
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	2f27e304-7a96-47b6-8ef1-8a649c25abcf	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076109 application number: ANDA076109

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
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	9624d675-0b7f-8630-e053-2a95a90a2fd0	1
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	9624d675-0b7f-8630-e053-2a95a90a2fd0	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	9624d675-0b7f-8630-e053-2a95a90a2fd0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-054-05	72189005405	1 mL in 1 BOTTLE (72189-054-05)	1 ml	2019-10-30	0000-00-00	No	No	Current