Ketorolac Tromethamine

Product NDC: 69452-275
Requested package NDC: 69452-275-20
11-digit product format: 694520275
Labeler code: 69452
Product ID: 69452-275_2f9eead4-1b34-d484-e063-6294a90afd42
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA216759
Marketing category: ANDA
Marketing start: 2023-03-10
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

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
A216759-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		2023-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216759-001	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	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216759-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`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	A216759-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216759-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216759-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216759-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216759-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216759-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216759-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216759-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216759-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216759-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216759-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216759-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216759-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216759-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216759-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216759-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216759-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216759-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216759-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216759-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216759-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216759-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216759-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216759-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216759-001	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
eda4b884-527c-42d3-971b-4d1678e5adbf	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
69452-275-20	Ketorolac Tromethamine	100 in 1 BOTTLE	TABLET, FILM COATED	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-275-20	EA - Each	69452-275	d82caf52-87a6-45ec-92bd-52f83f5fd03f	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-275	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BIONPHARMA INC.]	6	Current NDC, 1 package rows	20250308_eda4b884-527c-42d3-971b-4d1678e5adbf.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.	04d5114e-332b-4ed0-85df-b276c1dc296c	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	St. Mary's Medical Park Pharmacy	2d552135-bde5-5fe9-e063-6394a90af433	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals Inc.	337afb4f-789f-4cac-817a-e4286664a71e	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Direct_Rx	19fffe42-a02d-26eb-e063-6294a90aea5a	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	38fc11a0-50d1-4ba5-8d46-331eb74a00d6	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Redpharm Drug	3b0aaf7f-c2fe-83c6-e063-6294a90a6f27	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	8f36fde8-bc59-4a59-8659-b173cfd15774	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bionpharma Inc.	eda4b884-527c-42d3-971b-4d1678e5adbf	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759 ndc (package): 69452-275-20 ndc (product): 69452-275 ndc11 (package): 69452027520
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	18981677-8049-4864-b31c-96a299e3194d	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216759 application number: ANDA216759

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	eda4b884-527c-42d3-971b-4d1678e5adbf	6
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	eda4b884-527c-42d3-971b-4d1678e5adbf	6
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	04d5114e-332b-4ed0-85df-b276c1dc296c	5
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	19fffe42-a02d-26eb-e063-6294a90aea5a	5
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	19fffe42-a02d-26eb-e063-6294a90aea5a	5
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	04d5114e-332b-4ed0-85df-b276c1dc296c	5
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	337afb4f-789f-4cac-817a-e4286664a71e	3
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	515464a7-16c5-2811-e063-6294a90aa451	3
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	521b3d09-df08-fcae-e063-6294a90a6545	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	337afb4f-789f-4cac-817a-e4286664a71e	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	515464a7-16c5-2811-e063-6294a90aa451	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	521b3d09-df08-fcae-e063-6294a90a6545	3
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	2d552135-bde5-5fe9-e063-6394a90af433	2
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	8f36fde8-bc59-4a59-8659-b173cfd15774	2
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	2d552135-bde5-5fe9-e063-6394a90af433	2
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	8f36fde8-bc59-4a59-8659-b173cfd15774	2
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	38fc11a0-50d1-4ba5-8d46-331eb74a00d6	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	3b0aaf7f-c2fe-83c6-e063-6294a90a6f27	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	18981677-8049-4864-b31c-96a299e3194d	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	38fc11a0-50d1-4ba5-8d46-331eb74a00d6	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	3b0aaf7f-c2fe-83c6-e063-6294a90a6f27	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	18981677-8049-4864-b31c-96a299e3194d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69452-275-20	69452027520	100 TABLET, FILM COATED in 1 BOTTLE (69452-275-20)	2023-03-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets, USP Rx only	REMEDYREPACK INC.	2026-08-28	HUMAN PRESCRIPTION DRUG LABEL	6
Ketorolac Tromethamine Tablets, USP Rx only	St. Mary's Medical Park Pharmacy	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	3
Ketorolac 10mg Tab 10CT	Injecta Medcial LLC	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	4
Ketorolac 10mg Tab UD 10CT	Injecta Medcial LLC	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	3
Ketorolac Tromethamine Tablets, USP Rx only	Preferred Pharmaceuticals Inc.	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	3
Ketorolac Tromethamine	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	5
Ketorolac Tromethamine Tablets, USP Rx only	Proficient Rx LP	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	1
Ketorolac Tromethamine Tablets, USP Rx only	Redpharm Drug	2025-07-29	HUMAN PRESCRIPTION DRUG LABEL	1
Ketorolac Tromethamine Tablets, USP Rx only	Bryant Ranch Prepack	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	2
Ketorolac Tromethamine Tablets, USP Rx only	Bionpharma Inc. \| OPTIMUS PHARMA PRIVATE LIMITED \| OrBion Pharmaceuticals Private Limited	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	6
Ketorolac Tromethamine Tablets, USP Rx only	A-S Medication Solutions	2024-10-09	HUMAN PRESCRIPTION DRUG LABEL	1