Ketorolac Tromethamine

Product NDC: 42291-358
11-digit product format: 422910358
Labeler code: 42291
Product ID: 42291-358_d57ace50-7581-b575-e053-2a95a90a9a93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA074754
Marketing category: ANDA
Marketing start: 2016-07-25
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 10 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-358		D	Discontinued by firm		2026-08-03
excluded package	package	42291-358	42291-358-01	D	Discontinued by firm		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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-358-01	EA - Each	42291-358	89ed8d1f-1412-4d41-9613-229cb752cf44	1	2016-09-02

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4EVE5946BQ	KETOROLAC TROMETHAMINE	74103-07-4	KETOROLAC TROMETHAMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-358-01	42291035801	100 TABLET, FILM COATED in 1 BOTTLE (42291-358-01)	2016-07-25	0000-00-00	No	No	Current