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 151 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mist	ALCOHOL	Derma Glove	b5bfd7f0-0f96-459e-84d4-24b2081ae46f	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Relief	LOTION	Derma Glove	e2f89d56-5624-4a94-8151-1edb508232ac	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Recovery	ALCOHOL	Derma Glove	06f74478-57aa-4b8d-b888-55e1ee4fbd45	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Relief	LOTION	Derma Glove	d3926f48-3a42-42df-a850-47b3914ba3b6	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Mist	ALCOHOL	Derma Glove	7c21ee1c-ce2a-464b-8269-cdb3e59db094	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand	LOTION	Derma Glove	bcd71f37-63aa-4ad9-a9be-e5519c7e66e7	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Relief	LOTION	Derma Glove	ffdfb167-0efa-4cd8-afdf-e1ff69ee6252	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Mist	ALCOHOL	Derma Glove	11c2939c-e77a-48f6-949c-9d508714012b	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Recovery	ALCOHOL	Derma Glove	e6cfe092-cb2c-441b-8897-98626c43bef8	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	18981677-8049-4864-b31c-96a299e3194d	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4EVE5946BQ
Hand	LOTION	Derma Glove	642cc56f-9f39-46be-bbd8-a2346a0efac4	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand	LOTION	Derma Glove	93736944-7535-4035-93aa-4771138af8e3	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Relief	LOTION	Derma Glove	39867f66-b641-4060-881d-161c2591d19c	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Relief	LOTION	Derma Glove	767cc1f2-89a2-4d0b-ae49-ad7b9afca18b	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Recovery	ALCOHOL	Derma Glove	b4ff67d6-27d6-4d31-a708-9c2e8d4f0f3e	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand	LOTION	Derma Glove	1c46e4da-7594-48b0-8e8d-803189118420	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Sanitizer	HAND SANITIZER UNSCENTED	CASAD Company, Inc	07a891a3-dcf7-438f-bbf7-a20b2aa7d7d7	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Mist	ALCOHOL	Derma Glove	dd849fb3-95af-4a32-9687-3b966d456fbb	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Sanitizer	HAND SANITIZER UNSCENTED	CASAD Company, Inc	0933de73-94b1-448e-b39f-ecffabf95288	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Recovery	ALCOHOL	Derma Glove	d8705086-7209-4f13-bd54-604c90495f0a	2024-10-09	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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