FDA.reportPublic FDA data

Milrinone Lactate in Dextrose

Product NDC
0143-9719
11-digit product format
001439719
Labeler code
0143
Product ID
0143-9719_e67caf04-0a9c-4638-90a6-c959c9e0b927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate in Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA090038
Marketing category
ANDA
Marketing start
2010-01-21
Substance
MILRINONE LACTATE
Active strength
200 ug/mL
Pharmacologic classes
Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Milrinone Lactate in Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILRINONE LACTATE200 ug/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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9719-01Milrinone Lactate in Dextrose100 mL in 1 CONTAINERINJECTION, SOLUTION1008
0143-9719-10Milrinone Lactate in Dextrose10 in 1 PACKAGEINJECTION, SOLUTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9719-01ML - Milliliter0143-9719c9438773-0c7c-419a-8b62-c01248d1788612016-10-06
0143-9719-10ML - Milliliter0143-9719e7dfbf99-0b1d-4ce1-948e-1d052fd80d7b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MILRINONE LACTATEACTIVE INGREDIENT9K8XR81MO8MILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1
MILRINONEACTIVE MOIETYJU9YAX04C7MILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKMILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9719MILRINONE LACTATE IN DEXTROSE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250311_4c2f052b-7ba2-4122-a50b-37ef2a834d61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791840milrinone lactate 20 MG in 100 ML InjectionPSN4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791842milrinone lactate 40 MG in 200 ML InjectionPSN4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791840100 ML milrinone lactate 0.2 MG/ML InjectionSCD4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791842200 ML milrinone lactate 0.2 MG/ML InjectionSCD4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791840milrinone lactate 20 MG per 100 ML InjectionSY4c2f052b-7ba2-4122-a50b-37ef2a834d618
1791842milrinone lactate 40 MG per 200 ML InjectionSY4c2f052b-7ba2-4122-a50b-37ef2a834d618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9719-0100143971901100 mL in 1 CONTAINER100 mlHistorical
0143-9719-100014397191010 CONTAINER in 1 PACKAGE (0143-9719-10) / 100 mL in 1 CONTAINER (0143-9719-01) 10 container2010-01-210000-00-00NoNoCurrent