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 155 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol WipesWIPE EM ALCOHOL WIPESShaoxing Elite Bio-Tech Co., Ltd.1f373096-d3d5-af7f-e063-6394a90a3b552024-08-08WarningsExact identifier
unii: 3K9958V90M
Smart Care BERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.eb81614a-8e67-4f0a-bfd6-bd15eed468e02024-08-08WarningsExact identifier
unii: 3K9958V90M
DermaCen Lotionized Hand SanitizerALCOHOLCentral Solutions Inc1f1e6c95-533f-d3e4-e063-6394a90a05602024-08-07WarningsExact identifier
unii: 3K9958V90M
Smart Care LEMON LIME HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.f021873f-b25c-433a-9d82-2bf9b10e6f8a2024-08-07WarningsExact identifier
unii: 3K9958V90M
Smart Care WATERMELON HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.dc2c772b-4bd4-4a5f-b89d-ad2ca36574e02024-08-07WarningsExact identifier
unii: 3K9958V90M
Sugar Cookie Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efc0e9e-b4eb-d2b0-e063-6394a90a77792024-08-06WarningsExact identifier
unii: 3K9958V90M
Lemon Lime Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efe7236-d7bd-2a1c-e063-6294a90a736e2024-08-06WarningsExact identifier
unii: 3K9958V90M
ketorolac tromethamineKETOROLAC TROMETHAMINEZydus Lifesciences Limited5a4192e8-d9e5-4f09-99f6-da5a648b1aac2024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
ketorolac tromethamineKETOROLAC TROMETHAMINEZydus Pharmaceuticals (USA) Inc.ffd84ef3-26ed-4810-952b-4f0e913c5e322024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEDR. REDDY'S LABORATORIES, INC.10827042-a2d4-44f9-837d-2023a3d552ff2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
FaciliproETHYL ALCOHOLEcolab Inc.71f2504a-2da3-4273-9603-47e4cf64ad242024-08-01WarningsExact identifier
unii: 3K9958V90M
Lymph/Spleen ComboADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUMDeseret Biologicals, Inc.afce86e2-cbfa-44d4-b803-bc2ad50533572024-07-31WarningsExact identifier
unii: 451W47IQ8X
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
ketorolac tromethamineKETOROLAC TROMETHAMINESun Pharmaceutical Industries, Inc.29a92a7c-68d1-489b-ba27-d788b31537952024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ
WhiskCare 375 Fragrance FreeALCOHOLWhisk Products, Inc.c6787b12-ab90-4305-a6cc-55fd2c57cd2d2024-07-26WarningsExact identifier
unii: 3K9958V90M
Shimmy Original Hand SanitizerALCOHOLShimmy Products LLCc4c135ed-3b6a-69c8-e053-2a95a90aad1c2024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Rose Hibiscus Hand SanitizerALCOHOLShimmy Products LLCc50b5044-31fd-672a-e053-2995a90a49fc2024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Meyer Lemon Hand SanitizerALCOHOLShimmy Products LLCc50b9543-e276-9052-e053-2a95a90a83252024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Neutral Hand SanitizerALCOHOLShimmy Products LLCdf2761b9-0fca-5e2a-e053-2a95a90a9b8d2024-07-25WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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