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 166 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Habit	CHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUS	Deseret Biologicals, Inc.	3d00a305-e15d-4419-97bd-332421d4a1b0	2024-03-15	Warnings	Exact identifier unii: QTT17582CB
Bladder Kidney Meridian Opener	APIS MELLIFICA, ARGENTUM NITRICUM, BERBERIS VULGARIS, CANTHARIS, EQUISETUM ARVENSE, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, RHUS TOX, SEPIA, TEREBINTHINA, THUJA OCCIDENTALIS	Deseret Biologicals, Inc.	08e96657-9b15-41e3-88e5-8915cefb43be	2024-03-15	Warnings	Exact identifier unii: 451W47IQ8X
Breathe	ARGENTUM NITRICUM, NATRUM MURIATICUM, SULPHUR, ACONITUM NAPELLUS, ARSENICUM ALBUM, RHUS TOX, ADENOSINUM CYCLOPHOSPHORICUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, LUNG (SUIS), MUCOSA NASALIS SUIS, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, ACETYLCHOLINE CHLORIDE, COUMARINUM, MALVIN, DYSENTERY BACILLUS, PROTEUS (MORGANI)	Deseret Biologicals, Inc	8dbdd623-a486-4cf8-acdb-ad051dc74348	2024-03-15	Warnings	Exact identifier unii: 451W47IQ8X
Aire-Master Hand Sanitizer	ALCOHOL	Whisk Products, Inc.	138fef3e-feb9-8788-e063-6394a90a4bad	2024-03-13	Warnings	Exact identifier unii: 3K9958V90M
Balanced Salt	SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE	B. Braun Medical Inc.	74ab8883-0a5f-46b4-8998-9358f6fd4ef4	2024-03-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Elevate	LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)	Deseret Biologicals, Inc.	5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b	2024-03-11	Warnings	Exact identifier unii: 451W47IQ8X
Transcend Alco-Foam Hand Sanitizer	ALCOHOL	Von Drehle Corporation	132b4d76-e08f-b359-e063-6394a90a95d4	2024-03-08	Warnings	Exact identifier unii: 3K9958V90M
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	9d4c4d88-43da-49dd-e053-2995a90af18d	2024-03-07	Warnings	Exact identifier unii: 451W47IQ8X
Virimmune	ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2022-2023), MORBILLINUM	Deseret Biologicals, Inc.	ce3962de-576a-49f6-8dc3-68ba7ad96e9f	2024-03-05	Warnings	Exact identifier unii: 451W47IQ8X
Oral Health	BORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANS	Deseret Biologicals, Inc.	81ffb30f-5255-4e16-ba9d-b0de909aa557	2024-03-05	Warnings	Exact identifier unii: QTT17582CB
PTS/Stress Remedy	KALI PHOSPHORICUM, AMBRA GRISEA, CACAO, PHOSPHORICUM ACIDUM, ARNICA MONTANA, CALCAREA CARBONICA, CEREBRUM SUIS, GLANDULA SUPRARENALIS SUIS, LITHIUM CARBONICUM, ACONITUM NAPELLUS, ARGEMONE MEXICANA, ARSENICUM ALBUM, CICUTA VIROSA, HYOSCYAMUS NIGER, IGNATIA TIGRINUM, NATRUM MURIATICUM, TARENTULA HISPANICA, STRAMONIUM, BUTHUS AUSTRALIS	Deseret Biologicals, Inc.	05341147-789a-4844-9412-6a3044e5eb18	2024-03-04	Warnings	Exact identifier unii: 451W47IQ8X
Instant Hand Sanitizer	ALCOHOL	Safetec of America, Inc.	0f6f2a67-4fed-407e-a2c5-51574a5bbf65	2024-03-01	Warnings	Exact identifier unii: 3K9958V90M
Instant Hand Sanitizer - Cocoa Butter	ETHYL ALCOHOL	Rejoice International, Inc.	97dee45e-53be-4b37-a427-fc24388c0e05	2024-02-28	Warnings	Exact identifier unii: 3K9958V90M
Instant Hand Sanitizer Aloe Vera	ETHYL ALCOHOL	Rejoice International, Inc.	1e28454c-f5d8-4d6e-91f9-bc4501b027c1	2024-02-28	Warnings	Exact identifier unii: 3K9958V90M
Instant Hand Sanitizer - Clear	ETHYL ALCOHOL	Rejoice International, Inc.	f0e637d9-d61e-466d-9e05-f906639dbaca	2024-02-28	Warnings	Exact identifier unii: 3K9958V90M
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International, Inc.	07b163e4-8f67-44e7-b5ef-f237023080e0	2024-02-28	Warnings	Exact identifier unii: 3K9958V90M
Instant Hand Sanitizer - Ice Clear	ETHYL ALCOHOL	Rejoice International, Inc.	605ec88a-2f4c-4716-8522-eb2748b43398	2024-02-28	Warnings	Exact identifier unii: 3K9958V90M
Instant Hand Sanitizer - Original	ETHYL ALCOHOL	Rejoice International, Inc.	bb9cc886-275e-4996-99dc-529f928b4905	2024-02-28	Warnings	Exact identifier unii: 3K9958V90M
XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe	ETHYL ALCOHOL	Rejoice International	2851ad2a-e108-424c-86d6-c898567695ef	2024-02-28	Warnings	Exact identifier unii: 3K9958V90M
XtraCare Hand Sanitizer Moisturize with Vitamin E	ETHYL ALCOHOL	Rejoice International	13c99570-0859-4310-843a-5eb266698eb3	2024-02-28	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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