FDA.reportPublic FDA data

NDC 0641-6043-01 - 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
0641-6043
Requested NDC
0641-6043-01
Package NDCs from labels
0641-6043-01, 0641-6043-25
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 - A-S Medication SolutionsA-S Medication Solutions2021-06-14HUMAN 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
0641-6043-01Ketorolac Tromethamine2 mL in 1 VIALINJECTION213
0641-6043-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6043KETOROLAC 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
0641-6043-01ML - Milliliter0641-604336c45488-a54c-43b3-84ee-8e73c00410a912013-02-13
0641-6043-25ML - Milliliter0641-60432417a382-ad3f-43d9-af6d-fd60b4dd63a712013-02-13

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 60 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hand sanitizer chocolate chip pancake scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO105d2927-59e1-46fb-ad48-ea45ed3051e82026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer MANDARIN ORANGE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO20a8d48d-aa4b-4904-84e9-54be5ddb43a02026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer FRESH GUAVA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9eece9a7-3340-47ea-98aa-152d285e4c012026-02-16WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer SWEET CHERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO990a5e7b-8fe4-4681-99eb-76445f9436a72026-02-16WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAmazon.com Services LLC490a3484-04d7-4a90-b203-71971a869e8d2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAmazon.com Services LLCe1bd99f5-8a96-442a-8c70-367df96c5cf02026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLVeritiv Operating Company3b8a41b3-54c5-f5c0-e063-6394a90a9fac2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLValu Merchandisers Company722abec8-5a05-4e6d-a7ea-da9d1009e8592026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLValu Merchandisers Companye8b82c44-cbe0-42b2-b920-fed8da8f79eb2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer CARAMEL DREAM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO65702a16-5a66-412a-b288-4d64488c1c422026-02-16WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer CHERRY BLOSSOM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCObabf61f9-f8e0-4423-bd53-9e0317b949962026-02-16WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer WILD WATERMELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOc9de44d4-50fa-460f-a443-b241e025db1e2026-02-16WarningsExact identifier
unii: 3K9958V90M
ketorolac tromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepack23e7b5f7-ea0d-468d-9d13-a95f9bf605c62026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
SOUR LEMON Hand Sanitizer VANILLA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOe69b4735-fd8e-498f-86d2-b4fcb0aa57e52026-02-16WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION Hand Sanitizer ISLAND COCONUT SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOa42fcba5-04fc-438f-ab5f-ea13f156689a2026-02-16WarningsExact identifier
unii: 3K9958V90M
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
SaniiSwabETHYL ALCOHOL 62%PolleyMed LLC3b06f3a4-de7f-0d16-e063-6394a90af0dc2026-02-14WarningsExact identifier
unii: 3K9958V90M
hand sanitizer strawberry matcha scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOc41a3736-ce58-497c-aeba-2830cbd8a93b2026-02-13WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION HAND SANITIZER ORANGE BLOSSOM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO432d32fa-e3d3-4740-94f0-4a828ef5bc232026-02-13WarningsExact identifier
unii: 3K9958V90M
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEBaxter Healthcare Corporation30a3ca20-8f98-478c-8a6b-aa617f0a17a32026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ

Reported adverse events (FAERS/openFDA)#

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