NDC 68083-318-01 - Milrinone Lactate

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
68083-318
Requested NDC
68083-318-01
Package NDCs from labels
68083-318-01, 68083-318-10
Manufacturer
Gland Pharma Limited
Effective date
2017-07-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Milrinone Lactate - Gland Pharma LimitedGland Pharma Limited2017-07-26Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68083-318-102020-01-31C16284748780-19d75b9d0-07cf-f424-e053-dadaa90a57ceRx only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-318MILRINONE LACTATE INJECTION [GLAND PHARMA LIMITED]2Legacy NDC20170728_fa8c2d27-bb10-4966-bd8e-193fd921ea17.zip

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 9 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Milrinone LactateMILRINONE LACTATEArmas Pharmaceuticals Inc.fde1e354-4f15-4ade-9ae3-db2ba67e04312023-04-05Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Milrinone LactateMILRINONE LACTATEFresenius Kabi USA, LLCac43ba6b-635d-4129-8eea-96f3f5a4785e2023-03-17Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Milrinone LactateMILRINONE LACTATE IN 5% DEXTROSEEugia US LLC4e489fab-75bc-4514-9bf2-85b8ed08a1b02023-02-01Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
522dab1f-bb94-46c8-8a75-cde7bda8bbcefa8c2d27-bb10-4966-bd8e-193fd921ea172022-10-11Warnings, Adverse reactionsExact identifier
spl set id: fa8c2d27-bb10-4966-bd8e-193fd921ea17
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Milrinone LactateMILRINONE LACTATESomerset Therapeutics, LLCce43e850-4e80-4c5b-8811-9cb65824768c2022-09-23Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Milrinone Lactate in DextroseMILRINONE LACTATE IN DEXTROSEHospira, Inc.5273ea17-6920-4bff-8c5b-20ea531a04232022-03-28Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Milrinone LactateMILRINONE LACTATEMeitheal Pharmaceuticals Inc.6c6b69f9-e229-4a93-a108-9eafdab614f02022-01-13Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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