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 65 of 204 · 4,069 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adventure Hand Sanitizer - Fragrance 80%ALCOHOLNICETY SOLUTIONS LLCa507c20e-37d8-ea80-e053-2a95a90a41d42026-01-29WarningsExact identifier
unii: 3K9958V90M
Adventure Hand Sanitizer - Unscented 80%ALCOHOLNICETY SOLUTIONS LLCa5077eb2-4adb-0680-e053-2995a90a2cef2026-01-29WarningsExact identifier
unii: 3K9958V90M
ESC Protecting Foam Hand SanitizerALCOHOLEcolab Inc.d0820c4c-b320-4d3d-8ee3-de24fbed227b2026-01-29WarningsExact identifier
unii: 3K9958V90M
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Singular Wipes fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLC867a25d2-3d2c-4dad-bbe8-84195c03a87d2026-01-27WarningsExact identifier
unii: 3K9958V90M
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.49455156-1072-14f5-e063-6294a90abdff2026-01-26WarningsExact identifier
unii: 3K9958V90M
Signature Select Instant Hand Sanitizer Wipes with Aloe VeraALCOHOLLiving Better Brands LLCcf4b671f-697a-47d3-921e-2de4330739182026-01-26WarningsExact identifier
unii: 3K9958V90M
Signature Select Advanced Hand Sanitizer with Aloe VeraALCOHOLLiving Better Brands LLCcbf0fead-0729-460b-82c0-1596c995cf2b2026-01-26WarningsExact identifier
unii: 3K9958V90M
Signature Select Advanced Hand SanitizerALCOHOLLiving Better Brands LLC6d1cc25b-d612-4aae-bdb0-304758ef8f0f2026-01-26WarningsExact identifier
unii: 3K9958V90M
Homworks Alcohol Wipes MultipurposeETHYL ALCOHOLAcadian Crossing Consumer Products, LLC.c9f0c3b3-5f39-dfa6-e053-2995a90a76442026-01-26WarningsExact identifier
unii: 3K9958V90M
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Juniper Clean Hand SanitizerALCOHOLKYNC Design LLCa6bb7f88-ac9b-4f72-e053-2995a90ac15c2026-01-23WarningsExact identifier
unii: 3K9958V90M
Toronova II SUIKKETOROLAC TROMETHAMINEAdvanced Rx of Tennessee, LLC49dd153c-10e8-505b-e063-6394a90a595f2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Smart Care WILD CHERRY BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.944a5834-ece6-46e5-bc15-70b25b8103e12026-01-23WarningsExact identifier
unii: 3K9958V90M
Covex Antibacterial Hand Sanitizer, COOL BREEZEALCOHOLDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1587e-1ae1-d34b-e053-2995a90a2ce92026-01-22WarningsExact identifier
unii: 3K9958V90M
Covex Antibacterial Hand Sanitizer, FRESH ALOEALCOHOLDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a19dd5-57b2-6c98-e053-2a95a90a96cd2026-01-22WarningsExact identifier
unii: 3K9958V90M
DOP Ethyl Alcohol 70%ETHYL ALCOHOLOmega & Delta Co., Inc.b96d85f8-739c-4b96-9dd5-8119ebf66c9f2026-01-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Rose LycheeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfcbe1-8e0c-1715-e063-6394a90a733f2026-01-21WarningsExact identifier
unii: 3K9958V90M
LIGHTS Insect Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.ccb4185c-1a67-4775-9392-16bc0f7df3cc2026-01-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLMY IMPORTS USA LLC48f0a73a-66b5-e7d0-e063-6394a90a23332026-01-21WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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