Ketorolac Tromethamine

Product NDC: 52959-512
11-digit product format: 529590512
Labeler code: 52959
Product ID: 52959-512_8e1a80b4-ffb1-424c-b35d-4986fa74e21f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA074754
Marketing category: ANDA
Marketing start: 2010-04-20
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 10 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-512		I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-08	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-09	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-10	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-12	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-14	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-15	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-20	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-30	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-40	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-512	52959-512-60	I	Inactivated by FDA	2026-08-03

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
A074754-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074754-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A074754-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	f47d4365-40a8-445b-99cd-49edad6a8ffc	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	0749f61d-12e6-4280-8f41-bd4df81e7ae6	2026-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Northwind Health Company, LLC	d17ed469-677b-4a2e-96a9-5cfd0f50ecd9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	American Health Packaging	48244614-53ec-47e6-ad48-50814bdcceb7	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	PD-Rx Pharmaceuticals, Inc.	add10ccd-c205-4512-9619-253290fa1152	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	9fdba2e6-969f-4624-b08b-a42f99e4eff9	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	c1717245-cef3-b3d7-e053-2a95a90a1ac5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Teva Pharmaceuticals USA, Inc.	688f5dec-a6db-43c6-a1f8-5df99d08d395	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	415a5393-296f-30e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	46dc8f62-e754-50e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	f713500a-20b8-8e20-c4cc-956805170335	2023-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	94c7c57a-fd1e-41ab-bc39-9a538f6011d1	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	f5170993-81a9-4eb7-95ac-60697a5ee1d7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754

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
52959-512-08	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-09	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-10	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-12	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-14	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-15	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-20	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-30	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-40	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only
52959-512-60	2019-11-13	C162847	48780-1	97449f38-c3ec-f6ea-e053-dbdaa90aa703	KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-512-08	Ketorolac Tromethamine	8 in 1 BOTTLE	TABLET, FILM COATED	8	1
52959-512-09	Ketorolac Tromethamine	9 in 1 BOTTLE	TABLET, FILM COATED	9	1
52959-512-10	Ketorolac Tromethamine	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
52959-512-12	Ketorolac Tromethamine	12 in 1 BOTTLE	TABLET, FILM COATED	12	1
52959-512-14	Ketorolac Tromethamine	14 in 1 BOTTLE	TABLET, FILM COATED	14	1
52959-512-15	Ketorolac Tromethamine	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
52959-512-20	Ketorolac Tromethamine	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
52959-512-30	Ketorolac Tromethamine	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
52959-512-40	Ketorolac Tromethamine	40 in 1 BOTTLE	TABLET, FILM COATED	40	1
52959-512-60	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
52959-512-08	EA - Each	52959-512	644156d2-8b0b-4b5e-b8fd-b4d5dce0e736	1	2012-07-24
52959-512-09	EA - Each	52959-512	0dd2c331-9e76-4b86-b5de-1ce87b69bc96	1	2012-07-24
52959-512-10	EA - Each	52959-512	ccff0e7e-59b9-4378-bb33-14976f636954	1	2012-07-24
52959-512-12	EA - Each	52959-512	cc3e541a-8565-4705-935c-e820e8e56372	1	2012-07-24
52959-512-14	EA - Each	52959-512	6512bde4-16e6-4917-9e38-470d43ecbb07	1	2012-07-24
52959-512-15	EA - Each	52959-512	8edc5b92-715a-4974-9212-a958bdfbff1d	1	2012-07-24
52959-512-20	EA - Each	52959-512	e156bf95-60b9-420d-9214-6b7232dc91ec	1	2012-07-24
52959-512-30	EA - Each	52959-512	2be69f1b-ae1b-484d-8f71-ffe005961ada	1	2012-07-24
52959-512-40	EA - Each	52959-512	f978d743-2bbe-40a3-92b2-23b11c811256	1	2012-07-24
52959-512-60	EA - Each	52959-512	84ce86cd-c042-46de-bd17-a52fb07ab4eb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
KETOROLAC TROMETHAMINE	ACTIVE MOIETY	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-512	KETOROLAC TROMETHAMINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 10 package rows	20111208_b701aef5-3f70-4bc2-abe7-7047b6a6e2a5.zip

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	b701aef5-3f70-4bc2-abe7-7047b6a6e2a5	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	b701aef5-3f70-4bc2-abe7-7047b6a6e2a5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-512-08	52959051208	8 in 1 BOTTLE	Historical
52959-512-09	52959051209	9 in 1 BOTTLE	Historical
52959-512-10	52959051210	10 in 1 BOTTLE	Historical
52959-512-12	52959051212	12 in 1 BOTTLE	Historical
52959-512-14	52959051214	14 in 1 BOTTLE	Historical
52959-512-15	52959051215	15 in 1 BOTTLE	Historical
52959-512-20	52959051220	20 in 1 BOTTLE	Historical
52959-512-30	52959051230	30 in 1 BOTTLE	Historical
52959-512-40	52959051240	40 in 1 BOTTLE	Historical
52959-512-60	52959051260	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only	H.J. Harkins Company, Inc. \| TEVA Pharmaceuticals USA Inc	2011-10-21	HUMAN PRESCRIPTION DRUG LABEL	1