Milrinone Lactate

Product NDC
72485-503
11-digit product format
724850503
Labeler code
72485
Product ID
72485-503_fde1e354-4f15-4ade-9ae3-db2ba67e0431
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA214380
Marketing category
ANDA
Marketing start
2023-04-05
Substance
MILRINONE LACTATE
Active strength
1 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 LACTATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9K8XR81MO8
Rxcui1791854, 1791859, 1791861

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
72485-503-01Milrinone Lactate01 in 1 CARTONINJECTION, SOLUTION011
72485-503-01Milrinone Lactate50 mL in 1 VIALINJECTION, SOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-503-01ML - Milliliter72485-503c20116b0-4417-472c-8ffe-d5638ebd171112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-503MILRINONE LACTATE INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230406_fde1e354-4f15-4ade-9ae3-db2ba67e0431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791854milrinone lactate 10 MG in 10 ML InjectionPSNfde1e354-4f15-4ade-9ae3-db2ba67e04311
1791859milrinone lactate 20 MG in 20 ML InjectionPSNfde1e354-4f15-4ade-9ae3-db2ba67e04311
1791861milrinone lactate 50 MG in 50 ML InjectionPSNfde1e354-4f15-4ade-9ae3-db2ba67e04311
179185410 ML milrinone lactate 1 MG/ML InjectionSCDfde1e354-4f15-4ade-9ae3-db2ba67e04311
179185920 ML milrinone lactate 1 MG/ML InjectionSCDfde1e354-4f15-4ade-9ae3-db2ba67e04311
179186150 ML milrinone lactate 1 MG/ML InjectionSCDfde1e354-4f15-4ade-9ae3-db2ba67e04311
1791854milrinone lactate 10 MG per 10 ML InjectionSYfde1e354-4f15-4ade-9ae3-db2ba67e04311
1791859milrinone lactate 20 MG per 20 ML InjectionSYfde1e354-4f15-4ade-9ae3-db2ba67e04311
1791861milrinone lactate 50 MG per 50 ML InjectionSYfde1e354-4f15-4ade-9ae3-db2ba67e04311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-503-01724850503011 VIAL in 1 CARTON (72485-503-01) / 50 mL in 1 VIAL1 vial2023-04-05NoNoCurrent