KETOROLAC TROMETHAMINE

Product NDC: 69315-260
11-digit product format: 693150260
Labeler code: 69315
Product ID: 69315-260_aedd35df-9c0a-4dfb-ac09-dcb63675a420
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: KETOROLAC TROMETHAMINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA215745
Marketing category: ANDA
Marketing start: 2024-03-01
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 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
A215745-001	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
A215745-001	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
2026-08-18 06:07:40	2026-07	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215745-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	2023-02-23	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215745-001	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
2026-08-18 06:07:40	2026-07	A215745-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215745-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215745-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215745-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215745-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215745-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215745-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215745-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215745-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215745-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215745-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215745-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215745-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215745-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215745-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215745-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215745-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215745-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215745-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215745-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215745-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215745-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215745-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215745-001	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
04df9620-6dcb-494a-83e2-6d28036be974	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
69315-260-01	KETOROLAC TROMETHAMINE	100 in 1 BOTTLE	TABLET, FILM COATED	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-260-01	EA - Each	69315-260	848c3e57-f590-457e-a5ee-62ff0b4e4a84	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-260	KETOROLAC TROMETHAMINE TABLET, FILM COATED [LEADING PHARMA, LLC]	8	Current NDC, 1 package rows	20240312_04df9620-6dcb-494a-83e2-6d28036be974.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	PD-Rx Pharmaceuticals, Inc.	862dd7b7-8ed5-42bf-870e-a45b86740226	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215745 application number: ANDA215745
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Leading Pharma, LLC	04df9620-6dcb-494a-83e2-6d28036be974	2024-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215745 application number: ANDA215745 ndc (product): 69315-260

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	862dd7b7-8ed5-42bf-870e-a45b86740226	12
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	862dd7b7-8ed5-42bf-870e-a45b86740226	12
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	04df9620-6dcb-494a-83e2-6d28036be974	8
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	04df9620-6dcb-494a-83e2-6d28036be974	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69315-260-01	69315026001	100 TABLET, FILM COATED in 1 BOTTLE (69315-260-01)	2024-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2025-07-17	HUMAN PRESCRIPTION DRUG LABEL	12
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg Rx only	Leading Pharma, LLC \| Carnegie Pharmaceuticals LLC	2024-02-16	HUMAN PRESCRIPTION DRUG LABEL	8