FDA.reportPublic FDA data

Milrinone Lactate

Product NDC
55150-287
11-digit product format
551500287
Labeler code
55150
Product ID
55150-287_1c966c02-f3de-40dd-83ec-1bc2a3de2c7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate in 5% Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA209666
Marketing category
ANDA
Marketing start
2020-09-03
Substance
MILRINONE LACTATE
Active strength
.2 mg/mL
Pharmacologic classes
Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Milrinone Lactate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILRINONE LACTATE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9K8XR81MO8
Rxcui1791840, 1791842

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16d2d4aa-89a2-4b1f-a2c3-337667c79e14Product name420240223
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
470a2760-2c85-45c1-b7d6-7a15ec1b4abfProduct name120210201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-287-01Milrinone Lactate1 in 1 POUCHINJECTION, SOLUTION15
55150-287-01Milrinone Lactate100 mL in 1 BAGINJECTION, SOLUTION1005
55150-287-10Milrinone Lactate10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-287MILRINONE LACTATE (MILRINONE LACTATE IN 5% DEXTROSE) INJECTION, SOLUTION [EUGIA US LLC]5Current NDC, Legacy NDC, 3 package rows20230621_4e489fab-75bc-4514-9bf2-85b8ed08a1b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791840milrinone lactate 20 MG in 100 ML InjectionPSN4e489fab-75bc-4514-9bf2-85b8ed08a1b05
1791842milrinone lactate 40 MG in 200 ML InjectionPSN4e489fab-75bc-4514-9bf2-85b8ed08a1b05
1791840100 ML milrinone lactate 0.2 MG/ML InjectionSCD4e489fab-75bc-4514-9bf2-85b8ed08a1b05
1791842200 ML milrinone lactate 0.2 MG/ML InjectionSCD4e489fab-75bc-4514-9bf2-85b8ed08a1b05
1791840milrinone lactate 20 MG per 100 ML InjectionSY4e489fab-75bc-4514-9bf2-85b8ed08a1b05
1791842milrinone lactate 40 MG per 200 ML InjectionSY4e489fab-75bc-4514-9bf2-85b8ed08a1b05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-287-01551500287011 in 1 POUCHHistorical
55150-287-105515002871010 POUCH in 1 CARTON (55150-287-10) / 1 BAG in 1 POUCH (55150-287-01) / 100 mL in 1 BAG10 pouch2020-09-030000-00-00NoNoCurrent