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 157 of 199 · 3,978 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5253 hand sanitizerETHYL ALCOHOLInnovation Specialties3ef15fec-bb7a-424a-a361-88a8f9503b5f2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc9bef34b7-fdd0-41ee-a140-ea82552aab472024-07-10WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc7824f5c7-3650-490f-92cd-46c8ec32d7be2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc5849d19f-5761-4500-9596-e705b78f14ae2024-07-10WarningsExact identifier
unii: 3K9958V90M
5406 hand sanitizerETHYL ALCOHOLInnovation Specialties8d83b133-1240-4ec8-9fca-e4cbb84f6caf2024-07-10WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLInnovation Specialties Incb2eee632-5a1d-4df5-99c8-8ceb3d644c942024-07-10WarningsExact identifier
unii: 3K9958V90M
5259 HAND SANITIZERETHYL ALCOHOLInnovation Specialties3923fe13-0e57-406a-afb9-3e9cef263dab2024-07-10WarningsExact identifier
unii: 3K9958V90M
Assorted Licensed Hand Sanitizer Grape 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1c9095ad-ce19-3666-e063-6394a90ae22d2024-07-09WarningsExact identifier
unii: 3K9958V90M
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUSETHYL ALCOHOLMY IMPORTS USA LLC1ccb78ed-36f9-a7d2-e063-6394a90a64772024-07-09WarningsExact identifier
unii: 3K9958V90M
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDERETHYL ALCOHOLMY IMPORTS USA LLC1ccb9671-1970-39f9-e063-6294a90ac0792024-07-09WarningsExact identifier
unii: 3K9958V90M
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLMY IMPORTS USA LLC1ccbc68e-2b6b-768c-e063-6294a90a643b2024-07-09WarningsExact identifier
unii: 3K9958V90M
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLMY IMPORTS USA LLC1ccbbc55-3f7d-76d1-e063-6294a90a55902024-07-09WarningsExact identifier
unii: 3K9958V90M
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb701f7-61c8-e5f4-e063-6294a90a0c3c2024-07-08WarningsExact identifier
unii: 3K9958V90M
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb77267-73ad-efd2-e063-6294a90a43f72024-07-08WarningsExact identifier
unii: 3K9958V90M
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb7d6ca-ef7e-5225-e063-6294a90aa6922024-07-08WarningsExact identifier
unii: 3K9958V90M
Sani Luxe Hand Sanitizer with AlcoholALCOHOLCeleste Industries Corporation1a259dcf-4d82-4a42-be1f-0e557e0940bd2024-07-08WarningsExact identifier
unii: 3K9958V90M
Sani LuxeALCOHOLCeleste Industries Corporationba0f4e72-c50a-41c0-e053-2995a90aeee12024-07-08WarningsExact identifier
unii: 3K9958V90M
Assorted Licensed Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc8a756-852f-6cf8-e063-6394a90a57e62024-07-08WarningsExact identifier
unii: 3K9958V90M
Assorted Licensed Hand Sanitizer Vanilla 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc90b2f-450f-1deb-e063-6394a90a64802024-07-08WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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