FDA.reportPublic FDA data

NDC 72485-502-01 - 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
72485-502
Requested NDC
72485-502-01
Package NDCs from labels
72485-502-01, 72485-502-10
Manufacturer
Armas Pharmaceuticals Inc. | Caplin Steriles Limited
Effective date
2023-04-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Milrinone Lactate - Armas Pharmaceuticals Inc. | Caplin Steriles LimitedArmas Pharmaceuticals Inc. | Caplin Steriles Limited2023-04-05Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-502-01Milrinone Lactate20 mL in 1 VIALINJECTION, SOLUTION201
72485-502-10Milrinone Lactate10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-502MILRINONE LACTATE INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230406_fde1e354-4f15-4ade-9ae3-db2ba67e0431.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-502-01ML - Milliliter72485-5021c4b801e-e8f4-4f77-a556-e7d90d0989d912023-06-06
72485-502-10ML - Milliliter72485-5023a4ed040-0a69-4b4c-b984-bc110f6061ad12023-06-06

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 · 196 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
application number: ANDA214380
ndc (package): 72485-502-01
ndc (package): 72485-501-10
ndc (package): 72485-501-01
ndc (package): 72485-503-01
ndc (package): 72485-502-10
ndc (product): 72485-501
ndc (product): 72485-503
ndc (product): 72485-502
ndc11 (package): 72485050201
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
spl id: fde1e354-4f15-4ade-9ae3-db2ba67e0431
spl set id: fde1e354-4f15-4ade-9ae3-db2ba67e0431
unii: 9K8XR81MO8
Milrinone LactateMILRINONE LACTATEFresenius Kabi USA, LLCac43ba6b-635d-4129-8eea-96f3f5a4785e2023-03-17Warnings, Adverse reactionsExact identifier
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
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
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
application number: ANDA214380
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
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
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
unii: 9K8XR81MO8
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Milrinone Lactate in DextroseMILRINONE LACTATEGland Pharma Limited838da14b-c070-4c09-b088-99e7c64d99642021-08-25Warnings, Adverse reactionsExact identifier
unii: 9K8XR81MO8

Reported adverse events (FAERS/openFDA)#

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