FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-04-10HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine Injection, USPGeneral Injectables and Vaccines, Inc.2018-07-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6041-01Ketorolac Tromethamine1 mL in 1 VIALINJECTION113
0641-6041-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6041KETOROLAC TROMETHAMINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20240411_0c2c75c9-ed7b-46a8-9543-429bf2d8f090.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6041-01ML - Milliliter0641-6041de1e773b-19d1-4632-93ac-345ac50a144912013-02-13
0641-6041-25ML - Milliliter0641-6041ad136187-25b4-4f4d-ab41-60a269c4d8cb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RKETOROLAC 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 142 of 200 · 3,984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InstantINSTANTUnlimited Salesbd310bb2-37e5-1ed7-e053-2995a90a36b42024-12-05WarningsExact identifier
unii: 3K9958V90M
ALPET E3 PLUS HAND SANITIZERALCOHOLBest Sanitizers, Inc.d6d64945-4cd4-4926-9ef9-898cea89e8112024-12-05WarningsExact identifier
unii: 3K9958V90M
SMART SAN HAND SANITIZERALCOHOLBest Sanitizers, Inc.1c018851-82e0-4f2c-8f40-31674cd6fe2b2024-12-05WarningsExact identifier
unii: 3K9958V90M
ALPET E3 HAND SANITIZER FOAMALCOHOLBest Sanitizers, Inc.53573e1a-a3f8-4598-8248-ec4a62392d002024-12-05WarningsExact identifier
unii: 3K9958V90M
SMART SAN HAND SANITIZER FRAGRANCE-FREEALCOHOLBest Sanitizers, Inc.bce412dc-21db-4c63-b4fc-33538cda74242024-12-05WarningsExact identifier
unii: 3K9958V90M
SMART SAN HAND SANITIZERALCOHOLBest Sanitizers, Inc.8a2cc051-604c-43a7-9f65-2f929b759daa2024-12-05WarningsExact identifier
unii: 3K9958V90M
OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d05fbe85-26de-0d24-e053-2a95a90ab5cb2024-12-05WarningsExact identifier
unii: 3K9958V90M
BLACK OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d334b7f0-01dc-7f59-e053-2a95a90a06b52024-12-05WarningsExact identifier
unii: 3K9958V90M
SprixKETOROLAC TROMETHAMINEZyla Life Sciences US LLC97005a1c-167e-4676-bae7-e49b38c36f9e2024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
alcohol pad 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.03a6e8d4-535d-b316-e063-6294a90aebf52024-12-04WarningsExact identifier
unii: 3K9958V90M
Watermelon Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f0f9885-2ad5-09de-e063-6394a90ad0d72024-12-03WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLTEKWELD SOLUTIONS, INC.45afc52b-9838-1729-e054-00144ff8d46c2024-12-03WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Calming LavenderALCOHOLGOJO Industries, Inc.72244148-ad7e-47cf-96ff-48fc7f25d67d2024-12-03WarningsExact identifier
unii: 3K9958V90M
Sanitizing Hand Mist UnscentedETHYL ALCOHOLALO New York LLCe194daee-2197-4718-e053-2a95a90a48902024-12-03WarningsExact identifier
unii: 3K9958V90M
Junior MovesANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB METSilver Star Brands822d5481-7854-3fe7-e053-2a91aa0abf552024-12-03WarningsExact identifier
unii: 451W47IQ8X
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
Migo-EaseACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLASilver Star Brands816837f5-4487-657d-e053-2991aa0a78f42024-12-03WarningsExact identifier
unii: 451W47IQ8X
Instant Hand AntisepticALCOHOLASP Global291eaa18-81f8-6907-e054-00144ff88e882024-12-03WarningsExact identifier
unii: 3K9958V90M
Aquabain Instant Hand SanitizerETHYL ALCOHOL 70%Industria La Popular, S.A.b2e4d58d-adff-3cb2-e053-2995a90a392e2024-12-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vanilla NoirALCOHOLBath & Body Works, Inc.284ee56f-36e1-c5f9-e063-6294a90a62512024-12-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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