Ketorolac Tromethamine

Product NDC: 68071-2443
11-digit product format: 680712443
Labeler code: 68071
Product ID: 68071-2443_c44434f6-7325-0858-e053-2a95a90aa14a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA210616
Marketing category: ANDA
Marketing start: 2018-10-11
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 10 mg/1
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: 2022-12-31
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	68071-2443		I	Inactivated by FDA		2026-08-17
excluded package	package	68071-2443	68071-2443-2	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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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	68071-2443-2	`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
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 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
68071-2443-2	2023-01-30	C162847	48780-1	f386c649-d42c-0266-e053-dadaa90a7c1a	KETOROLAC TROMETHAMINE- ketorolac tromethamine tablet, film coated Cycle Pharmaceuticals Ltd. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2443-2	Ketorolac Tromethamine	20 in 1 BOTTLE	TABLET, FILM COATED	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2443	KETOROLAC TROMETHAMINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20210609_c44434f6-7326-0858-e053-2a95a90aa14a.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	c44434f6-7326-0858-e053-2a95a90aa14a	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	c44434f6-7326-0858-e053-2a95a90aa14a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2443-2	68071244302	20 TABLET, FILM COATED in 1 BOTTLE (68071-2443-2)	2021-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KETOROLAC TROMETHAMINE- ketorolac tromethamine tablet, film coated Cycle Pharmaceuticals Ltd. Rx only	NuCare Pharmaceuticals,Inc.	2021-06-08	HUMAN PRESCRIPTION DRUG LABEL	1