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 112 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer, Cherry Pie ScentedALCOHOLFourstar Group USA, Inc.89d8771b-e6eb-4a09-9d06-8c7a692243bd2025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Confetti Cake ScentedALCOHOLFourstar Group USA, Inc.4e87ec93-7e9b-4a6e-8286-93dc1e75c2f52025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Jasmine Dragon Fruit ScentedALCOHOLFourstar Group USA, Inc.144da5c7-45e9-4980-a61c-81c3b9d8e7872025-06-17WarningsExact identifier
unii: 3K9958V90M
Alco Hand SanitizerALCOHOLWoodbine Products Company3bd696e2-9125-4604-ace9-d931d9fb5ea32025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Peach ScentedALCOHOLFourstar Group USA, Inc.340879c5-4a51-44ca-9b28-9f24a1111efd2025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Strawberry Cake ScentedALCOHOLFourstar Group USA, Inc.d4db52eb-d207-410e-bcc0-08a97eb141cc2025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care CARAMEL HONEY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.ffd8dfae-3205-455d-8bbe-9e9f8ee859e12025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET CITRUS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5bcc5f69-713c-45c5-aa19-6a1086c71c352025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care JUICY BERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.8f9feca1-59e9-4be9-9b89-0a615be159ef2025-06-16WarningsExact identifier
unii: 3K9958V90M
Smart Care PISTACHIO BRULE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.3a88b38c-f754-4756-be73-e1c03fe607302025-06-16WarningsExact identifier
unii: 3K9958V90M
Lacura Moisturizing Hand SanitizerETHYL ALCOHOL 62%Aldidafa52fe-42e6-2c21-e053-2995a90a413f2025-06-13WarningsExact identifier
unii: 3K9958V90M
RefresherALCOHOLJao Limited1debc8ca-2ea4-40c3-ad1e-8c1dc763d0f82025-06-13WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Sugar Plum ScentedALCOHOLFourstar Group USA, Inc.5a1a58d4-dddf-45f7-a327-b18a6eed44d42025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Cucumber Melon HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.cdae74d9-48a7-47dc-b006-8e2b0c2562572025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Citrus HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3c1581c6-c615-463e-83ad-cc84391b80e72025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.371ef8bb-9e3e-e5cc-e063-6394a90a4b6e2025-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer SpidermanALCOHOLShenzhen Lantern Scicence Co.,Ltd.371f6cbb-0164-e82d-e063-6294a90ae2df2025-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer --SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.371b5429-a392-02d0-e063-6294a90a7fe82025-06-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer TransformerALCOHOLShenzhen Lantern Scicence Co.,Ltd.371c47f6-ba88-4a7c-e063-6294a90a16972025-06-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Passion Fruit HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0fec6b2c-21ac-44ae-8e84-5e3795fdd5d52025-06-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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