FDA.reportPublic FDA data

Milrinone Lactate

Product NDC
65145-121
11-digit product format
651450121
Labeler code
65145
Product ID
65145-121_0de424df-9ffa-4223-9850-9d644c803825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA214380
Marketing category
ANDA
Marketing start
2025-02-14
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
65145-121-01Milrinone Lactate20 mL in 1 VIALINJECTION, SOLUTION205
65145-121-10Milrinone Lactate10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-121-01ML - Milliliter65145-12117be79a0-33d4-4183-937b-ea636203be6212025-06-13
65145-121-10ML - Milliliter65145-12141d23bd8-52a4-4a9c-8536-6890262e947d12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-121MILRINONE LACTATE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]5Current NDC, Legacy NDC, 2 package rows20250216_cbe097f8-9599-4f5b-bdf3-3f43d3e3461b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791854milrinone lactate 10 MG in 10 ML InjectionPSNcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5
1791859milrinone lactate 20 MG in 20 ML InjectionPSNcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5
1791861milrinone lactate 50 MG in 50 ML InjectionPSNcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5
179185410 ML milrinone lactate 1 MG/ML InjectionSCDcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5
179185920 ML milrinone lactate 1 MG/ML InjectionSCDcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5
179186150 ML milrinone lactate 1 MG/ML InjectionSCDcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5
1791854milrinone lactate 10 MG per 10 ML InjectionSYcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5
1791859milrinone lactate 20 MG per 20 ML InjectionSYcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5
1791861milrinone lactate 50 MG per 50 ML InjectionSYcbe097f8-9599-4f5b-bdf3-3f43d3e3461b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65145-121-016514501210120 mL in 1 VIAL20 mlHistorical
65145-121-106514501211010 VIAL in 1 CARTON (65145-121-10) / 20 mL in 1 VIAL (65145-121-01) 10 vial2025-02-140000-00-00NoNoCurrent