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 100 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Ocean MistALCOHOLScent Theory Products LLC3f8fd236-e413-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Sunrise CitrusALCOHOLScent Theory Products LLC3f8fd236-e415-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Velvet VanillaALCOHOLScent Theory Products LLC3f8fdb54-2e2c-2cab-e063-6394a90a1f092025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Sun-Kissed MelonALCOHOLScent Theory Products LLC3f8fe3c4-1373-b45a-e063-6294a90ae05b2025-09-24WarningsExact identifier
unii: 3K9958V90M
Unishield Hand SanitizerETHYL ALCOHOLUnishieldeae1fc97-eb39-4353-adfa-7c549d50b5db2025-09-24WarningsExact identifier
unii: 3K9958V90M
Smart Care WATERMELON HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.dd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b2025-09-24WarningsExact identifier
unii: 3K9958V90M
First Aid Direct Hand SanitizerHAND SANITIZERCintas Corporationdad0fc5d-4a48-4db1-b423-558c2958750c2025-09-24WarningsExact identifier
unii: 3K9958V90M
Tendersant Hand SanitizerALCOHOLGeri-Gentle Corporationb09d568a-4c9d-5804-e053-2a95a90ab8ea2025-09-23WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA SUGAR HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.bad645e8-4f99-4629-9259-9ae856e16d302025-09-22WarningsExact identifier
unii: 3K9958V90M
Smart Care Cherry Blossom HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e04b42dd-68ce-44d9-be1b-c4a5d9a646612025-09-19WarningsExact identifier
unii: 3K9958V90M
Smart Care HAND SANITIZER - CUCUMBER MELON FLAVORETHYL ALCOHOLAshtel Studios Inc.153a921a-a721-4320-8b86-cfed1ea511272025-09-19WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
meijer LAKESHORE FRESH SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.f0214101-0800-4ac2-a622-38192eeec5e32025-09-19WarningsExact identifier
unii: 3K9958V90M
meijer PINE FOREST SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.bb81ef16-bb89-4a1a-a8f9-305c5e7468c82025-09-19WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Pea HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.a67aef1b-c0b2-4626-b89b-58a6b56efe1c2025-09-19WarningsExact identifier
unii: 3K9958V90M
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
Ketorolac TromethamineKETOROLAC TROMETHAMINEProPharma Distribution3f2956d9-9e68-f35e-e063-6394a90a706d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665461
unii: 4EVE5946BQ
AcularKETOROLAC TROMETHAMINEAllergan, Inc.c94644d3-7b64-4f3d-a0c7-12c77466a0fc2025-09-18Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
MISTIFY SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3efef0a5-ff5e-f2b0-e063-6294a90a1efa2025-09-17WarningsExact identifier
unii: 3K9958V90M
MISTIFY SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3eff0ac8-1cf5-3681-e063-6294a90a87052025-09-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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