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 96 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
BCBGENERATION HAND SANITIZER PEONY BLUSH SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO3f53a401-86d9-45d6-a526-5efd00546a032025-10-13WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer SUGAR MACARON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO4d4dae53-e00b-4ce4-8e14-ba38583fdaf22025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care MY LITTLE PONY SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.073a8f7d-a1d4-4cb3-94f8-efb449f96b472025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care TRANSFORMER SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.6fe631ed-d76d-4076-ae29-e4b2133a4ef02025-10-13WarningsExact identifier
unii: 3K9958V90M
Be Smart Get Prepared Sting Relief WipeBENZOCAINE, ALCOHOLTotal Resources International, Inc5415073f-aa1d-4ed3-aa30-7470cd2efed12025-10-10WarningsExact identifier
unii: 3K9958V90M
Lemyn Organics Medical-Grade Hand SanitizerALCOHOLLemyn LLCb106289d-346a-74df-e053-2995a90aa4262025-10-10WarningsExact identifier
unii: 3K9958V90M
Be Smart Get Prepared Sting Relief WipeALCOHOL, LIDOCAINE HYDROCHLORIDETotal Resources International, Incfff6f057-739e-40f1-8427-e1364c65af052025-10-09WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Hudson Import& Export Co., Ltd40b6c96c-e36f-6588-e063-6394a90adb462025-10-09WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER CHERRY ON TOPETHYL ALCOHOLPearl World Inc.218fc79e-5a57-4561-9986-f723dc12928d2025-10-09WarningsExact identifier
unii: 3K9958V90M
DigiSanALCOHOLEcolab Inc.aa921967-cd15-4bc2-9452-7637462747022025-10-09WarningsExact identifier
unii: 3K9958V90M
365 Spiced Balsam Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10cd38f9-dbe0-8bea-e063-6294a90a39872025-10-08WarningsExact identifier
unii: 3K9958V90M
365 Winterberry Saffron Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10bc43da-460a-d30d-e063-6294a90a49402025-10-08WarningsExact identifier
unii: 3K9958V90M
365 Spiced Citrus Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10d096e7-3fb9-6122-e063-6294a90a20c02025-10-08WarningsExact identifier
unii: 3K9958V90M
North Woods Derma Gel ClearALCOHOLSuperior Chemical Corporationabbd099a-8d89-80a0-e053-2a95a90a24fc2025-10-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLAvaria Health & Beauty Corpa3d87ef6-752b-b54b-e053-2a95a90af9632025-10-08WarningsExact identifier
unii: 3K9958V90M
Novo Foaming Instant Hand SanitizerETHYL ALCOHOLNoble Chemical Inc.0f126636-9606-3aea-e063-6294a90ae3c62025-10-08WarningsExact identifier
unii: 3K9958V90M
Reddy Lab Advanced Alcohol Gel SanitizerALCOHOLFlavor Reddy Foods, LLCb9f76aec-d052-69d2-e053-2995a90a277f2025-10-08WarningsExact identifier
unii: 3K9958V90M
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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