Ketorolac Tromethamine

Product NDC: 72189-371
11-digit product format: 721890371
Labeler code: 72189
Product ID: 72189-371_ea75fe43-6872-f0e9-e053-2a95a90a35fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA210616
Marketing category: ANDA
Marketing start: 2022-08-10
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 10 mg/1
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: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	72189-371		D	Discontinued by firm	2026-08-17
excluded package	package	72189-371	72189-371-10	D	Discontinued by firm	2026-08-17
excluded package	package	72189-371	72189-371-15	D	Discontinued by firm	2026-08-17
excluded package	package	72189-371	72189-371-20	D	Discontinued by firm	2026-08-17
excluded package	package	72189-371	72189-371-30	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 · 10 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
2025-01-20 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	72189-371-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-371-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-371-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-371-30	`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	72189-371-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-371-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-371-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-371-30	`0efc9e666f02…`	`f202fb6c5f17…`

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
A210616-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		2018-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210616-001	AB

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	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210616-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2018-08-16	`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	A210616-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210616-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210616-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210616-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210616-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210616-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210616-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210616-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210616-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210616-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210616-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210616-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210616-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210616-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210616-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210616-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210616-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210616-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210616-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210616-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210616-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210616-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210616-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210616-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210616-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210616-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210616-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210616-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210616-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210616-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210616-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210616-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210616-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210616-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210616-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210616-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210616-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210616-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210616-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210616-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-371-10	EA - Each	72189-371	6bbc2630-34d3-4b5c-93a4-1eba784eb53b	1	2022-11-07
72189-371-15	EA - Each	72189-371	3c9cb11d-8963-4efc-8d5c-58131d25f92e	1	2022-09-12
72189-371-20	EA - Each	72189-371	b96862bf-4c97-408d-8e3e-860e2af4d9a8	1	2022-09-12
72189-371-30	EA - Each	72189-371	7988d79c-c63d-4801-8b35-4100dce4833b	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-371	KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT_RX]	6	Legacy NDC	20250123_e5e7f0cf-70ba-2247-e053-2a95a90a314d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Chartwell RX, LLC	3855f527-fd6c-4f24-a4b4-cd47eec1193d	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210616 application number: ANDA210616

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-371-10	72189037110	10 TABLET, FILM COATED in 1 BOTTLE (72189-371-10)	2022-08-10	0000-00-00	No	No	Current
72189-371-15	72189037115	15 TABLET, FILM COATED in 1 BOTTLE (72189-371-15)	2022-08-10	0000-00-00	No	No	Current
72189-371-20	72189037120	20 TABLET, FILM COATED in 1 BOTTLE (72189-371-20)	2022-08-10	0000-00-00	No	No	Current