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 141 of 200 · 3,984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Han-SanHAN-SANPro-Line Industrial Productsbd4a5c7e-af8b-d08d-e053-2995a90ac7722024-12-08WarningsExact identifier
unii: 3K9958V90M
Gel Antiseptic HandwashGEL ANTISEPTIC HANDWASHShop Bee's Wax LLCbdac168b-5d58-69ba-e053-2995a90aa5a42024-12-08WarningsExact identifier
unii: 3K9958V90M
InstantINSTANTDetco Industriesbd9a0b41-4861-adfc-e053-2a95a90ae7a02024-12-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERKandel & Sonbd9a7ce4-1b61-742f-e053-2995a90aa0f02024-12-08WarningsExact identifier
unii: 3K9958V90M
Antiseptic Gel HandwashANTISEPTIC GEL HANDWASHSafeSpace Co.bd969c73-af6c-6bb3-e053-2995a90a6a3f2024-12-08WarningsExact identifier
unii: 3K9958V90M
Sani GelSANI GELOmega Industrial Supplybda9bd59-9825-27ba-e053-2a95a90a30022024-12-08WarningsExact identifier
unii: 3K9958V90M
Sani-LotionSANI-LOTIONTifco Industriesbd4a4a57-fa8a-ade8-e053-2a95a90ab3672024-12-08WarningsExact identifier
unii: 3K9958V90M
Germ FreeGERM FREECompetitive Choicebd997c76-4e01-56a7-e053-2995a90a70c52024-12-08WarningsExact identifier
unii: 3K9958V90M
Slap HappySLAP HAPPYBeaver Research Companybd48b6e1-d93e-5616-e053-2995a90aca392024-12-06WarningsExact identifier
unii: 3K9958V90M
Express Wipes Hand SanitizerHAND SANITIZER WIPEQuestSpecialty Corporation7873b8fc-8f79-3019-e053-2991aa0a8a6a2024-12-06WarningsExact identifier
unii: 3K9958V90M
Bacti-GoneBACTI-GONEBeta Technology,Incbe4c1c52-c03a-5bd8-e053-2995a90a4cc72024-12-06WarningsExact identifier
unii: 3K9958V90M
Contact Instant Antiseptic Hand SanitizerCONTACT INSTANT ANTISEPTIC HAND SANITIZERUnited Laboratories, Inc.eedb3eb2-6224-f26d-e053-2995a90aec7d2024-12-06WarningsExact identifier
unii: 3K9958V90M
Alco-SanALCO-SANMid-American Research Chemical Corp.ba2306ff-d66c-fe4b-e053-2995a90a05f72024-12-06WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer KE-53SANINSTANT HAND SANITIZER KE-53SANKinzua Environmentald9a829a7-851a-3811-e053-2a95a90a2b902024-12-06WarningsExact identifier
unii: 3K9958V90M
BLUESEA DISPOSABLE HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTD7a552be2-a9e1-4c6f-b1c2-79113a73bd2f2024-12-06WarningsExact identifier
unii: 3K9958V90M
BLUESEA INSTANT HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTDe6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd2024-12-06WarningsExact identifier
unii: 3K9958V90M
Instant Hand AntisepticALCOHOLASP Globalb84075db-be0c-4265-b262-825bc6ade9d82024-12-06WarningsExact identifier
unii: 3K9958V90M
Instant Hand AntisepticALCOHOLASP Global9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2024-12-06WarningsExact identifier
unii: 3K9958V90M
Toronova SUIKKETOROLAC TROMETHAMINEAdvanced Rx of Tennessee, LLC275f9131-5915-a585-e063-6294a90ab0fc2024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
PURELL Advanced Hand Sanitizer Energizing MintALCOHOLGOJO Industries, Inc.a77f2ac3-2a8c-45e7-a65e-bd58e834249b2024-12-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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