FDA.reportPublic FDA data

NDC 0409-1983-01 - Milrinone Lactate in Dextrose

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
0409-1983
Requested NDC
0409-1983-01
Package NDCs from labels
0409-1983-01, 0409-1983-10
Manufacturer
Hospira, Inc. | Gland Pharma Limited | Wuhan Biocause Pharmaceutical Development Co., Ltd
Effective date
2022-03-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Milrinone Lactate in 5% Dextrose InjectionHospira, Inc. | Gland Pharma Limited | Wuhan Biocause Pharmaceutical Development Co., Ltd2022-03-28Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1983-01Milrinone Lactate in Dextrose200 mL in 1 BAGINJECTION, SOLUTION2002
0409-1983-01Milrinone Lactate in Dextrose1 in 1 POUCHINJECTION, SOLUTION12
0409-1983-10Milrinone Lactate in Dextrose10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1983MILRINONE LACTATE IN DEXTROSE INJECTION, SOLUTION [HOSPIRA, INC.]2Current NDC, Legacy NDC, 3 package rows20220404_5273ea17-6920-4bff-8c5b-20ea531a0423.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1983-01ML - Milliliter0409-1983016e55dc-ca9b-4585-9e50-81028d8d36b212021-11-09
0409-1983-10ML - Milliliter0409-1983414d3187-71ff-4ac0-b946-d7712118199f12021-11-09

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 14 of 16 · 317 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
25% Dextrose Infant25% DEXTROSE INFANTHF Acquisition Co. LLC, DBA Health First73d04839-a2bb-65dd-e053-2991aa0a82ca2022-12-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Company9c80dfee-8923-4d1f-85b0-98bd68b942122022-12-07Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Corporation50603082-bce5-49eb-9737-e04239cfb6952022-12-07Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: LX22YL083G
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: LX22YL083G
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: LX22YL083G
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
DextroseDEXTROSE MONOHYDRATEMedical Purchasing Solutions, LLC66713d9c-f404-4ec8-e053-2a91aa0a620a2022-10-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEMedical Purchasing Solutions, LLC677bb6d6-704b-5be5-e053-2991aa0a5f6f2022-10-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dextrose MonohydrateDEXTROSE MONOHYDRATEMedical Purchasing Solutions, LLCdc6664a6-1be1-676c-e053-2995a90a34902022-10-07Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
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
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: LX22YL083G
Milrinone Lactate in DextroseMILRINONE LACTATE IN DEXTROSEHospira, Inc.5273ea17-6920-4bff-8c5b-20ea531a04232022-03-28Warnings, Adverse reactionsExact identifier
application number: ANDA213585
ndc (package): 0409-2045-01
ndc (package): 0409-1983-10
ndc (package): 0409-1983-01
ndc (package): 0409-2045-10
ndc (product): 0409-2045
ndc (product): 0409-1983
ndc11 (package): 00409198301
rxcui: 1791840
rxcui: 1791842
spl id: 41afad76-bea1-46c5-ab31-84a54b157410
spl set id: 5273ea17-6920-4bff-8c5b-20ea531a0423
unii: 9K8XR81MO8
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: LX22YL083G
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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