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 99 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CleanBoss Hand Sanitizing GelETHYL ALCOHOLInnovative Biodefensed91c5753-eb27-1d1c-e053-2a95a90a888a2025-10-02WarningsExact identifier
unii: 3K9958V90M
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LP38fc11a0-50d1-4ba5-8d46-331eb74a00d62025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
FRESH FEELS HAND SANITIZER MIST PINEAPPLE SCENTETHYL ALCOHOLPearl World Inc.36853a90-74fa-4427-814a-d703e68a6dde2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MIXED BERRY SCENTETHYL ALCOHOLPearl World Inc.f48def31-3a9c-49fb-817b-5fca781ad88a2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST STRAWBERRY SCENTETHYL ALCOHOLPearl World Inc.70963fc5-926c-446a-abe6-b828436255db2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY SCENTETHYL ALCOHOLPearl World Inc.3e77d397-ef6c-4898-8e87-31023b44dc362025-10-01WarningsExact identifier
unii: 3K9958V90M
Fresh Feels Hand Sanitizer MistFRESH FEELS HAND SANITIZER MISTZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3ffda86b-6b1d-8f0d-e063-6394a90aafaf2025-09-30WarningsExact identifier
unii: 3K9958V90M
Lavender Hand Sanitizer WipesETHANOLWhole Foods Market, Inc.0398573a-44fa-e0c6-e063-6394a90a99242025-09-30WarningsExact identifier
unii: 3K9958V90M
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEOnesource Specialty Pharma Limited4596483b-990b-eaa4-e063-6394a90ac08f2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEOnesource Specialty Pharma Limited45966992-5af6-bf10-e063-6294a90af25b2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Ketorolac TromethamineKETOROLAC TROMETHAMINEMicro Labs Limited631c2c31-cd4f-4a17-85c6-be96746a753e2025-09-29Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
PURELL Hand Sanitizer SP Berry and CitrusALCOHOLGOJO Industries, Inc.3fb7bccb-a699-a10d-e063-6294a90a49bc2025-09-26WarningsExact identifier
unii: 3K9958V90M
Fresh Feels Hand SanitizerFRESH FEELS HAND SANITIZERZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3e36e2c4-fe4d-d517-e063-6394a90ac4be2025-09-25WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(CHERRY)HAND SANITIZER(CHERRY)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6cc842-8b54-9a27-e063-6294a90a1dd52025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(PEACH)HAND SANITIZER(PEACH)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6bf6be-5328-8151-e063-6294a90a82112025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(COCONUT)HAND SANITIZER(COCONUT)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6ca090-98d9-4650-e063-6294a90a35c02025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(MANGO)HAND SANITIZER(MANGO)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6c79b9-d4b1-bbaf-e063-6394a90a11002025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Matcha MoodALCOHOLScent Theory Products LLC3f8fc09d-863d-0c13-e063-6394a90a49682025-09-24WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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