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 75 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: 451W47IQ8X
SSDC Alphasan Hand SanitizerALCOHOLEcolab Inc.bbb0f924-3224-47f0-85b2-ebe024f8f9582025-12-31WarningsExact identifier
unii: 3K9958V90M
Kay Alcohol Foam Hand SanitizerALCOHOLEcolab Inc.37429e8a-581d-443e-8e8a-71fbb53c7c562025-12-31WarningsExact identifier
unii: 3K9958V90M
QSR Hand SanitizerALCOHOLEcolab Inc.901abea4-b82e-43c7-a1ac-0cdc1555dbc22025-12-31WarningsExact identifier
unii: 3K9958V90M
Ecolab Retail Foaming Alcohol Hand SanitizerALCOHOLEcolab Inc.e3f6eb96-05fe-4b20-bb72-954cdc47ffcb2025-12-31WarningsExact identifier
unii: 3K9958V90M
FIRST MARK ULTRA HAND SANITIZERALCOHOLPerformance Food Group80a490b4-dae5-4851-b3e6-2e558cdc51e52025-12-30WarningsExact identifier
unii: 3K9958V90M
EcolabALCOHOLEcolab Inc.f8561810-9d12-4c05-a547-b41bbb5170a92025-12-30WarningsExact identifier
unii: 3K9958V90M
PureForceALCOHOLEcolab Inc.775ee6e6-b3f8-4b97-b2b1-6f3a2defc6962025-12-30WarningsExact identifier
unii: 3K9958V90M
XHC-79ETHYL ALCOHOLEcolab Inc.ac662ae2-3228-4cce-9a20-96e1c234c27a2025-12-30WarningsExact identifier
unii: 3K9958V90M
EcolabALCOHOLEcolab Inc.a02591df-f121-4b92-8d0a-d4ef5edce1192025-12-30WarningsExact identifier
unii: 3K9958V90M
HandSanitizerGelBloodOrangeGC-HAND SANITIZER GEL-BLOOD ORANGENaturich Labs, Incfc628374-4794-0d31-e053-6394a90af64a2025-12-30WarningsExact identifier
unii: 3K9958V90M
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Alcohol Gel Hand SanitizerALCOHOLEcolab Inc.6305da7a-f21c-4e94-a2c1-e1faac489df62025-12-30WarningsExact identifier
unii: 3K9958V90M
Protecting FHSALCOHOLEcolab50d1e501-c143-4446-84e7-7f3f278166af2025-12-30WarningsExact identifier
unii: 3K9958V90M
Facilipro Protecting FHSALCOHOLEcolabd6fccda4-f565-406b-aeb6-585b59bddf512025-12-30WarningsExact identifier
unii: 3K9958V90M
Retail Hand SanitizerALCOHOLEcolab Inc.55e65545-9869-413b-8239-bd2d43fe36d82025-12-30WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 62ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.e6b2cc57-11a6-4808-a30f-8118a8de9fc62025-12-29WarningsExact identifier
unii: 3K9958V90M
Refreshify Antiseptic Hand WipesALCOHOLEmes Commerce Group Inc.46d2f10e-e1c2-3ca2-e063-6394a90a602d2025-12-29WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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