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 34 of 204 · 4,069 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lightning X Hand CleanserETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.51861f1e-8961-e876-e063-6394a90a2fd02026-05-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERETHYL ALCOHOLLESSDOTW CO.,LTD.518657d5-9ee6-f8ca-e063-6294a90af5952026-05-11WarningsExact identifier
unii: 3K9958V90M
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Beverly Gel Hand SanitizerETHYL ALCOHOLCleanslate Group LLC0e999251-cb51-ceec-e063-6294a90a35ad2026-05-11WarningsExact identifier
unii: 3K9958V90M
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
SANAR DECOLORIZED IODINEETHYL ALCOHOLEVI LABS518d399a-009e-c54f-e063-6294a90ab8382026-05-11WarningsExact identifier
unii: 3K9958V90M
Amora Hand Sanitizer WatermelonALCOHOLI World LLC45f9b0a2-972f-4d44-aad1-8999313d41912026-05-11WarningsExact identifier
unii: 3K9958V90M
Amora Hand Sanitizer CherryALCOHOLI World LLCd9445e2a-e7f0-41ab-9b89-17cdf9fd7d5f2026-05-11WarningsExact identifier
unii: 3K9958V90M
Amora Hand Sanitizer CoconutALCOHOLI World LLCdded6a0c-3bed-453e-a2ea-d3406f2c89762026-05-11WarningsExact identifier
unii: 3K9958V90M
WalgreensETHYL ALCOHOLWalgreenseff97d19-8f15-5ea7-e053-2995a90aeae42026-05-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLApollo Health and Beauty Cared09dc034-92d2-765d-e053-2995a90afd582026-05-08WarningsExact identifier
unii: 3K9958V90M
HiGHMARKALCOHOLApollo Health and Beauty Caref9643d82-ae87-ea72-e053-6394a90ad82f2026-05-08WarningsExact identifier
unii: 3K9958V90M
WalgreensETHYL ALCOHOLWalgreenebf222f0-dc46-ee73-e053-2a95a90a07212026-05-08WarningsExact identifier
unii: 3K9958V90M
WalgreensETHYL ALCOHOLWalgreensebf222f0-dc45-ee73-e053-2a95a90a07212026-05-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLApollo Health and Beauty Care35a64b83-12b2-3d69-e063-6294a90a19e72026-05-08WarningsExact identifier
unii: 3K9958V90M
Autumn Bliss Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Carea259d254-52ae-4612-aa9e-a36480ad151a2026-05-08WarningsExact identifier
unii: 3K9958V90M
Winter Frost Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Careac3577f8-f3be-4dc7-a4da-652688c32d062026-05-08WarningsExact identifier
unii: 3K9958V90M
Sweet Cinnamon Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Carefa78fb62-ca61-4fc8-a11a-74340dfa3d662026-05-08WarningsExact identifier
unii: 3K9958V90M
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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