NDC 0641-6041-01 - Ketorolac Tromethamine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0641-6041
Requested NDC: 0641-6041-01
Package NDCs from labels: 0641-6041-01, 0641-6041-25
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2024-04-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ketorolac Tromethamine - Hikma Pharmaceuticals USA Inc.	Hikma Pharmaceuticals USA Inc.	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine Injection, USP	General Injectables and Vaccines, Inc.	2018-07-02	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6041-01	Ketorolac Tromethamine	1 mL in 1 VIAL	INJECTION	1		13
0641-6041-25	Ketorolac Tromethamine	25 in 1 CARTON	INJECTION	25		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6041	KETOROLAC TROMETHAMINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	13	Current NDC, Legacy NDC, 2 package rows	20240411_0c2c75c9-ed7b-46a8-9543-429bf2d8f090.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6041-01	ML - Milliliter	0641-6041	de1e773b-19d1-4632-93ac-345ac50a1449	1	2013-02-13
0641-6041-25	ML - Milliliter	0641-6041	ad136187-25b4-4f4d-ab41-60a269c4d8cb	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	KETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

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 156 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	f55bd888-5e01-474d-871b-24654c070178	2024-07-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Symmetry Foaming Hand Sanitizer	ALCOHOL	Buckeye International, Inc.	bcab4842-50ff-4c7f-8b85-0126f4b585b0	2024-07-23	Warnings, Adverse reactions	Exact identifier unii: 3K9958V90M
Altra Hand Sanitizer with Aloe and Vitamin E	ALCOHOL	Buckeye International, Inc.	a2974445-eaa3-d9f0-e053-2995a90a78fc	2024-07-23	Warnings	Exact identifier unii: 3K9958V90M
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	d1920335-8e45-4960-b6e9-e6f1f9e6820c	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1665459 rxcui: 860092 rxcui: 1665461 unii: 4EVE5946BQ
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	83994d0c-8484-4505-abb5-8a384ed12288	2024-07-22	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
LAVENDER SCENTED HAND SANITIZER PEN	ALCOHOL	Fourstar Group USA, Inc.	5c27f212-4010-44de-9e9d-758ffdfcc5c1	2024-07-18	Warnings	Exact identifier unii: 3K9958V90M
CITRUS SCENTED HAND SANITIZER PEN	ALCOHOL	Fourstar Group USA, Inc	b3c59433-a4cd-42cb-9492-fcdc19ca765c	2024-07-18	Warnings	Exact identifier unii: 3K9958V90M
COCONUT SCENTED HAND SANITIZER PEN	ALCOHOL	Fourstar Group USA, Inc.	2fa53710-c084-48e0-8300-511d0d93a88d	2024-07-18	Warnings	Exact identifier unii: 3K9958V90M
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Eugia US LLC	f520978f-9046-4ff8-b04d-0f615fdeae4d	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1665459 rxcui: 860092 rxcui: 1665461 unii: 4EVE5946BQ
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	ae2e626c-0019-7c4e-e053-2995a90a23be	2024-07-17	Warnings, Adverse reactions	Exact identifier unii: 4EVE5946BQ
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID MONOHYDRATE	American Health Packaging	58fa9952-c8ab-4ebb-a073-15cc45f4832a	2024-07-16	Adverse reactions	Exact identifier unii: XF417D3PSL
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Alembic Pharmaceuticals Inc.	419cf756-3c96-4bb8-ae96-6aea5a5f3afd	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1665459 rxcui: 860092 rxcui: 1665461 unii: 4EVE5946BQ
sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	8df7dcf6-8714-6caf-e053-2995a90ab8cc	2024-07-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
b.pure Hand Sanitizer Lemon Scented	ALCOHOL	FOURSTAR GROUP USA, INC.	bc35f9ec-e453-4994-91ae-2294d058e45d	2024-07-12	Warnings	Exact identifier unii: 3K9958V90M
Thompson Safety Eyewash	WATER	Thompson Safety	1d0e96cf-245b-cfb7-e063-6294a90a4ced	2024-07-12	Warnings	Exact identifier unii: 059QF0KO0R
b.pure Hand Sanitizer Watermelon Scented	ALCOHOL	FOURSTAR GROUP USA, INC.	e0ed1b57-2d7e-4e63-96f5-dbbb2aef26df	2024-07-12	Warnings	Exact identifier unii: 3K9958V90M
b.pure Hand Sanitizer Green Apple Scented	ALCOHOL	FOURSTAR GROUP USA, INC.	7c870d8f-c298-4469-b6d1-f318f6adfd26	2024-07-12	Warnings	Exact identifier unii: 3K9958V90M
Ecolab Facilipro	ALCOHOL	Ecolab Inc.	87aa66da-bbc7-4d02-851b-63c19e68578a	2024-07-12	Warnings	Exact identifier unii: 3K9958V90M
Antiseptic Hand Sanitizer	ETHYL ALCOHOL	Innovation Specialties Inc	b80b88e1-e35c-47de-89ee-314d6054f4ce	2024-07-10	Warnings	Exact identifier unii: 3K9958V90M
ANTISEPTIC HAND SANITIZER	ETHYL ALCOHOL	Innovation Specialties Inc	89af8a07-49cd-4b51-9ca7-016f849d7b70	2024-07-10	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.