Ketorolac Tromethamine

Product NDC: 50090-7638
11-digit product format: 500907638
Labeler code: 50090
Product ID: 50090-7638_31c46849-c104-43f5-aa02-74873756a3e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA215788
Marketing category: ANDA
Marketing start: 2025-01-18
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A215788-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		2022-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215788-001	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
2026-02-19 14:30 UTC	2026-02	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215788-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-03-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215788-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215788-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215788-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215788-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215788-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215788-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215788-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215788-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215788-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215788-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215788-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215788-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215788-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215788-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215788-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215788-001	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215788-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215788-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215788-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215788-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215788-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215788-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215788-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215788-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215788-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215788-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215788-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215788-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215788-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215788-001	AB	1	`a50c72e98297…`

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
0952d430-2665-4952-ba06-ab99f054f4df	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7638-0	Ketorolac Tromethamine	20 in 1 BOTTLE	TABLET, FILM COATED	20		1
50090-7638-3	Ketorolac Tromethamine	10 in 1 BOTTLE	TABLET, FILM COATED	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7638-0	EA - Each	50090-7638	161321f3-adaf-4592-a0a7-cf4c325966da	1	2025-10-14
50090-7638-3	EA - Each	50090-7638	bbe492d5-67a8-4d16-99e7-97379ad2950c	1	2025-10-14

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Amerisyn LLC	5734e81e-2471-1314-e063-6294a90ac9fe	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Major Pharmaceuticals	48245718-a2df-4938-8d06-3b8abf34181e	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Northwind Health Company, LLC	08674066-7d4b-936d-e063-6394a90abbd7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	37453bcd-e34b-5902-e063-6294a90a0245	2025-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Amici Pharma Inc.	8b26240c-b72b-42a6-ab33-a1e38224fbe0	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	18b450d2-e715-4710-a1d8-22b782f87f9c	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	0952d430-2665-4952-ba06-ab99f054f4df	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788 ndc (product): 50090-7638
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	afc691f8-517a-4d88-8322-87dafec8f064	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Golden State Medical Supply, Inc.	ec6d453b-4b84-53d4-e053-2995a90a6006	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Ajanta Pharma USA Inc.	36713fb3-d301-432d-a95d-06e368fc8a22	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	f4e7f1c8-e458-0860-e053-2a95a90a1bf0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	6fa20b41-f860-4fea-b1fb-ab6d3fa34a90	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	DR. REDDY'S LABORATORIES, INC.	10827042-a2d4-44f9-837d-2023a3d552ff	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	9e5fde54-2206-4072-afb8-4d06a8d314b1	2023-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215788 application number: ANDA215788

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	0952d430-2665-4952-ba06-ab99f054f4df	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	0952d430-2665-4952-ba06-ab99f054f4df	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7638-0	50090763800	20 TABLET, FILM COATED in 1 BOTTLE (50090-7638-0)	2025-08-25	No	No	Current
50090-7638-3	50090763803	10 TABLET, FILM COATED in 1 BOTTLE (50090-7638-3)	2025-08-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets USP, 10 mg	A-S Medication Solutions	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL	1