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 134 of 200 · 3,984 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sweat-Less	ARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MUR	Silver Star Brands	4053d10b-4b06-291b-e054-00144ff88e88	2025-01-01	Warnings	Exact identifier unii: 451W47IQ8X
NativeRemedies Triple Complex Brain Tonic	CALC PHOS, KALI PHOS, NAT MUR.	Silver Star Brands	f76eaf46-4a80-31a9-e053-6394a90a542d	2025-01-01	Warnings	Exact identifier unii: 451W47IQ8X
Headache Ease	AUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIA	Silver Star Brands	c689fb16-6200-ac94-e053-2995a90a703d	2025-01-01	Warnings	Exact identifier unii: 451W47IQ8X
AllergiClear-M	ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA	Silver Star Brands	9d36096b-022f-5cfa-e053-2995a90a381f	2025-01-01	Warnings	Exact identifier unii: 451W47IQ8X
Stress Away Anxiety Relief	ACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUM	Silver Star Brands	05e04129-e7c1-4e11-e063-6394a90a09ca	2025-01-01	Warnings	Exact identifier unii: QTT17582CB
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDY	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d02e4d6-8751-b5bc-e063-6394a90a9d97	2025-01-01	Warnings	Exact identifier unii: 3K9958V90M
Total Solutions Hand Sanitizing Wipes	ALCOHOL	Athea Laboratories, Inc.	2dd15f06-5ca6-524d-e063-6294a90a277e	2025-01-01	Warnings	Exact identifier unii: 3K9958V90M
Hand Sanitizer	ALCOHOL	Lil' Drug Store Products, Inc	c8c75368-b27d-47a6-bb73-35b15abc3211	2024-12-31	Warnings	Exact identifier unii: 3K9958V90M
Hand Sanitizer	ALCOHOL	Lil' Drug Store Products, Inc.	1bb77439-c2b4-431d-8c3b-e78b5431a18a	2024-12-31	Warnings	Exact identifier unii: 3K9958V90M
DG Health Sterile Saline Mist	SODIUM CHLORIDE	DG Health	f2e44ab4-ae0f-c87b-e053-2a95a90acd04	2024-12-31	Warnings	Exact identifier unii: 451W47IQ8X
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 unii: 4EVE5946BQ
Ketorocaine LM Kit	KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE	Advanced Rx Pharmacy of Tennessee, LLC	fb81d452-30e0-f019-e053-6394a90a7634	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1665461
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	f4e7f1c8-e458-0860-e053-2a95a90a1bf0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4EVE5946BQ
Instant Hand Sanitizer	ETHYL ALCOHOL	Hillyard GMP	f1aa2ef0-79b4-4f8b-8333-805623a94306	2024-12-31	Warnings	Exact identifier unii: 3K9958V90M
Hillyard Foaming Instant Hand Sanitizer	ALCOHOL	Hillyard GMP	4acdbf3e-fa79-468f-9e18-fcf9b1f35707	2024-12-30	Warnings	Exact identifier unii: 3K9958V90M
ethanol	DERMA FOAM EXCEL HAND SANITIZER	Superior Chemical Co DBA NorthWoods	26e26d6b-4f1a-46f7-e063-6394a90a3e7d	2024-12-27	Warnings	Exact identifier unii: 3K9958V90M
Gut Brain Spectrum	ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM	Energique, Inc.	adfee6ce-05b0-4955-bf5f-9612b8db4c78	2024-12-26	Warnings	Exact identifier unii: 451W47IQ8X
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOL	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	2a23ed29-20c3-ab51-e063-6394a90a13a2	2024-12-25	Warnings	Exact identifier unii: 3K9958V90M
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOL	ETHYL ALCOHOL	MY IMPORTS USA LLC	2a24bfc4-cf6e-29a4-e063-6394a90afa78	2024-12-25	Warnings	Exact identifier unii: 3K9958V90M
TREE ANTIGEN	POPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLE	Natural Creations, Inc	8040ab36-90eb-4076-a478-9b82ccfa4ec9	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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