ketorolac tromethamine

Product NDC: 68071-2983
11-digit product format: 680712983
Labeler code: 68071
Product ID: 68071-2983_33a10385-9c5e-478b-e063-6294a90a1a20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA217038
Marketing category: ANDA
Marketing start: 2022-11-10
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: 2026-12-31
Current FDA listing: Yes

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 · 6 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
2025-02-02 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	68071-2983-2	`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	68071-2983-2	`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	68071-2983-2	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217038-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		2022-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217038-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217038-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-10-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217038-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217038-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217038-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217038-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217038-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217038-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217038-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217038-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217038-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217038-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217038-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217038-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217038-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217038-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217038-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217038-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217038-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217038-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217038-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217038-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217038-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217038-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217038-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217038-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A217038-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A217038-001	AB	1	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217038-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ketorolac tromethamine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOROLAC TROMETHAMINE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4EVE5946BQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834022	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe7eb195-48be-753b-e053-6294a90a8500	Available on FDA.report

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
68071-2983-2	2025-02-10	C162847	48780-1	2cef2736-90af-d83d-e063-dadaa90ab31f	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
68071-2983-2	2025-01-30	C162847	48780-1	2cef2736-90af-d83d-e063-dadaa90ab31f	Ketorolac Tromethamine Tablets USP, 10 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2983-2	ketorolac tromethamine	20 in 1 BOTTLE	TABLET, FILM COATED	20		3
68071-2983-8	ketorolac tromethamine	28 in 1 BOTTLE	TABLET, FILM COATED	28		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2983	KETOROLAC TROMETHAMINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, 2 package rows	20250427_fe7eb195-48be-753b-e053-6294a90a8500.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	b0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	1e7ae5af-76b9-49a9-ba14-52b566929c22	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	51d443f8-716d-af3a-e063-6394a90a56a3	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	23e7b5f7-ea0d-468d-9d13-a95f9bf605c6	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	d8e928ac-c1e7-4b7a-87cd-9d11e36d53c0	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	fe7eb195-48be-753b-e053-6294a90a8500	2025-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038 ndc (product): 68071-2983
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Zydus Lifesciences Limited	5a4192e8-d9e5-4f09-99f6-da5a648b1aac	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Zydus Pharmaceuticals (USA) Inc.	ffd84ef3-26ed-4810-952b-4f0e913c5e32	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038
ketorolac tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	155c9171-d394-9c28-e063-6394a90a8209	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217038 application number: ANDA217038

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	fe7eb195-48be-753b-e053-6294a90a8500	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	fe7eb195-48be-753b-e053-6294a90a8500	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-2983-2	68071298302	20 TABLET, FILM COATED in 1 BOTTLE (68071-2983-2)	2023-06-19	No	No	Current
68071-2983-8	68071298308	28 TABLET, FILM COATED in 1 BOTTLE (68071-2983-8)	2025-04-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	NuCare Pharmaceuticals,Inc.	2025-04-25	HUMAN PRESCRIPTION DRUG LABEL	3