Ketorolac Tromethamine

Product NDC: 80425-0489
Requested package NDC: 80425-0489-2
11-digit product format: 804250489
Labeler code: 80425
Product ID: 80425-0489_2cf758ae-264f-cb5a-e063-6394a90aab02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA216651
Marketing category: ANDA
Marketing start: 2025-01-30
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 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
A216651-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		2022-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216651-001	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	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216651-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2022-08-25	`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	A216651-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216651-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216651-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216651-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216651-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216651-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216651-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216651-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216651-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216651-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216651-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216651-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216651-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216651-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216651-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216651-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216651-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216651-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216651-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216651-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216651-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216651-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216651-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216651-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216651-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216651-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216651-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216651-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216651-001	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
2cf7516b-ac86-ca72-e063-6394a90a4339	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	SPL version
80425-0489-1	Ketorolac Tromethamine	9 in 1 BOTTLE	TABLET, FILM COATED	9	1
80425-0489-2	Ketorolac Tromethamine	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
80425-0489-3	Ketorolac Tromethamine	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
80425-0489-4	Ketorolac Tromethamine	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
80425-0489-5	Ketorolac Tromethamine	60 in 1 BOTTLE	TABLET, FILM COATED	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0489-1	EA - Each	80425-0489	b38a6c0a-008a-4e55-bd99-e2a9150e408b	1	2025-03-04
80425-0489-2	EA - Each	80425-0489	197e9d54-12dc-41d7-8981-94db5390ce8e	1	2025-03-04
80425-0489-3	EA - Each	80425-0489	a8041135-84a2-43be-bab8-fc2ee60fc7ea	1	2025-03-04
80425-0489-4	EA - Each	80425-0489	5bb9bbbb-a4a1-4245-a676-71e6785ec4cf	1	2025-03-04
80425-0489-5	EA - Each	80425-0489	b4eaefe5-140e-45e6-b470-da643623ca7f	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0489	KETOROLAC TROMETHAMINE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 5 package rows	20250201_2cf7516b-ac86-ca72-e063-6394a90a4339.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Injecta Medcial LLC	515464a7-16c5-2811-e063-6294a90aa451	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216651 application number: ANDA216651
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Injecta Medcial LLC	521b3d09-df08-fcae-e063-6294a90a6545	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216651 application number: ANDA216651
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	49e04373-568d-48fa-ac1c-b7d6b493e777	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216651 application number: ANDA216651
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx of Tennessee, LLC	2cf7516b-ac86-ca72-e063-6394a90a4339	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216651 application number: ANDA216651 ndc (package): 80425-0489-2 ndc (product): 80425-0489 ndc11 (package): 80425048902
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Camber Pharmaceuticals, Inc.	e1fb8753-4695-4cb2-83d7-15d79fbaeeb2	2022-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216651 application number: ANDA216651

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	2cf7516b-ac86-ca72-e063-6394a90a4339	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	2cf7516b-ac86-ca72-e063-6394a90a4339	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0489-2	80425048902	10 TABLET, FILM COATED in 1 BOTTLE (80425-0489-2)	2025-01-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets, USP Rx only	Advanced Rx of Tennessee, LLC	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	1