FDA.reportPublic FDA data

NDC 70069-807-01 - 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
70069-807
Requested NDC
70069-807-01
Package NDCs from labels
70069-807-01, 70069-807-10
Manufacturer
Somerset Therapeutics, LLC | Caplin Steriles Limited
Effective date
2022-09-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Milrinone Lactate - Somerset Therapeutics, LLC | Caplin Steriles LimitedSomerset Therapeutics, LLC | Caplin Steriles Limited2022-09-23Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-807-01Milrinone Lactate10 mL in 1 VIALINJECTION, SOLUTION101
70069-807-10Milrinone Lactate10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-807MILRINONE LACTATE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]1Current NDC, Legacy NDC, 2 package rows20221001_ce43e850-4e80-4c5b-8811-9cb65824768c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-807-01ML - Milliliter70069-807b4397476-6e03-4053-9a87-7b6f6b09341a12022-11-07
70069-807-10ML - Milliliter70069-807aff3e6e7-cf0a-4a8b-89e5-42f60d5003d212022-11-07

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
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
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
ndc (package): 70069-808-10
ndc (package): 70069-809-01
ndc (package): 70069-808-01
ndc (package): 70069-807-01
ndc (package): 70069-807-10
ndc (product): 70069-808
ndc (product): 70069-809
ndc (product): 70069-807
ndc11 (package): 70069080701
rxcui: 1791861
rxcui: 1791859
rxcui: 1791854
spl id: ce43e850-4e80-4c5b-8811-9cb65824768c
spl set id: ce43e850-4e80-4c5b-8811-9cb65824768c
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.