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 62 of 204 · 4,069 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hua Jing Alcohol Prep Pad (Thick)HUA JING ALCOHOL PREP PAD (THICK)Hua Jing Medical Supplies INC.4a65fc2d-a6b5-c091-e063-6394a90a1d5a2026-02-10WarningsExact identifier
unii: 3K9958V90M
Walgreens ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTWALGREEN COMPANY48fef521-1b1d-d0d5-e063-6394a90ac7b12026-02-10WarningsExact identifier
unii: 451W47IQ8X
Walgreens SALINE MISTNASAL MISTWALGREEN COMPANY44815675-cc1d-a582-e063-6394a90ae8f62026-02-10WarningsExact identifier
unii: 451W47IQ8X
Ethyl Rubbing AlcoholETHYL ALCOHOLWalgreen Co.a08ef11f-5c4f-4821-a0c0-d6c89def0bea2026-02-10Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Smart Care JAPANESE CHERRY BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.bd25ab3b-d91e-4e61-a574-d0ec9037c41f2026-02-10WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLRetail Business Services, LLC8ba8176f-ddbd-48d7-bb62-74a499ea667c2026-02-06Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLRetail Business Services, LLC135ae232-3be4-4bbe-98fd-65eef3a675ad2026-02-06Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLSalado Sales Inc.2869f574-e74c-492c-b3fa-b256b468746b2026-02-06Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand Sanitizer Cherry PopALCOHOLScent Theory Products LLC4a18b475-fd3b-10a3-e063-6294a90a4f472026-02-05WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Ocean SplashALCOHOLScent Theory Products LLC4a18d7b2-94ca-7924-e063-6394a90af3d12026-02-05WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Banana CremeALCOHOLScent Theory Products LLC4a18e8e0-43e3-70d8-e063-6294a90adf4b2026-02-05WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Juicy PearALCOHOLScent Theory Products LLC4a18e8e0-43e5-70d8-e063-6294a90adf4b2026-02-05WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Pink MelonALCOHOLScent Theory Products LLC4a18ec9c-d466-63c1-e063-6294a90a11222026-02-05WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLPublix Super Markets, Inc.11ef0139-940f-444d-a8f8-98f693ccff222026-02-05Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand Sanitizer 8 oz. Vitamin E 70 v/vETHYL ALCOHOLNingbo Rejoice Internationala26a6f97-7166-0a40-e053-2a95a90a4b682026-02-05WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Vitamin E and Aloe VeraETHYL ALCOHOLNingbo Rejoice Internationala26a4676-6eae-088a-e053-2a95a90a7c1a2026-02-05WarningsExact identifier
unii: 3K9958V90M
Tork Hand Sanitizing Alcohol FoamALCOHOLEssity Professional Hygiene North America LLC3987934e-2bf9-4c80-8842-2ad294e485862026-02-04WarningsExact identifier
unii: 3K9958V90M
Ethyl AlcoholETHYL ALCOHOLGeorgia-Pacific Consumer Products LPa935425d-f86b-41e9-bbce-1a028e302e102026-02-04Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
enMotion Foam High Frequency UseETHYL ALCOHOLGeorgia-Pacific Consumer Products LPe56f5a94-0be1-487b-ad95-c1fe74c824ee2026-02-04Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Pacific Blue Ultra Foaming Fragrance FreeETHYL ALCOHOLGeorgia-Pacific Consumer Products LP0bdc1b9a-0a56-466b-ac51-95c499e909782026-02-04Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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