FDA.reportPublic FDA data

Milrinone Lactate in Dextrose

Product NDC
68083-410
11-digit product format
680830410
Labeler code
68083
Product ID
68083-410_4522009c-38db-44c1-8d16-c44f674a9920
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA213585
Marketing category
ANDA
Marketing start
2020-07-16
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 in Dextrose
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
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
68083-410-01Milrinone Lactate in Dextrose1 in 1 CARTONINJECTION, SOLUTION14
68083-410-01Milrinone Lactate in Dextrose100 mL in 1 BAGINJECTION, SOLUTION1004
68083-410-10Milrinone Lactate in Dextrose10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-410MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [GLAND PHARMA LIMITED]4Current NDC, Legacy NDC, 3 package rows20210826_838da14b-c070-4c09-b088-99e7c64d9964.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791840milrinone lactate 20 MG in 100 ML InjectionPSN838da14b-c070-4c09-b088-99e7c64d99644
1791842milrinone lactate 40 MG in 200 ML InjectionPSN838da14b-c070-4c09-b088-99e7c64d99644
1791840100 ML milrinone lactate 0.2 MG/ML InjectionSCD838da14b-c070-4c09-b088-99e7c64d99644
1791842200 ML milrinone lactate 0.2 MG/ML InjectionSCD838da14b-c070-4c09-b088-99e7c64d99644
1791840milrinone lactate 20 MG per 100 ML InjectionSY838da14b-c070-4c09-b088-99e7c64d99644
1791842milrinone lactate 40 MG per 200 ML InjectionSY838da14b-c070-4c09-b088-99e7c64d99644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-410-01680830410011 in 1 CARTONHistorical
68083-410-106808304101010 CARTON in 1 CARTON (68083-410-10) / 1 BAG in 1 CARTON (68083-410-01) / 100 mL in 1 BAG10 carton2020-07-160000-00-00NoNoCurrent