FDA.reportPublic FDA data

Milrinone Lactate

Product NDC
0143-9710
11-digit product format
001439710
Labeler code
0143
Product ID
0143-9710_7805629b-e6dc-4763-9a78-87b1b4ad91f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA077966
Marketing category
ANDA
Marketing start
2010-12-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
0143-9710-01Milrinone Lactate10 mL in 1 VIALINJECTION, SOLUTION1022
0143-9710-10Milrinone Lactate10 in 1 BOXINJECTION, SOLUTION1022
0143-9710-25Milrinone Lactate25 in 1 BOXINJECTION, SOLUTION2522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9710-01ML - Milliliter0143-97109a6fa5e7-63f1-41de-8ebf-2417225193a712015-07-20
0143-9710-10ML - Milliliter0143-97104245d0f1-04f9-4b94-81ba-ca068c24e1e812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MILRINONE LACTATEACTIVE INGREDIENT9K8XR81MO8MILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
MILRINONEACTIVE MOIETYJU9YAX04C7MILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKMILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RMILRINONE LACTATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9710MILRINONE LACTATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]21Current NDC, Legacy NDC, 3 package rows20250515_88f78780-399f-4780-be19-205739db1682.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791854milrinone lactate 10 MG in 10 ML InjectionPSN88f78780-399f-4780-be19-205739db168222
1791859milrinone lactate 20 MG in 20 ML InjectionPSN88f78780-399f-4780-be19-205739db168222
1791861milrinone lactate 50 MG in 50 ML InjectionPSN88f78780-399f-4780-be19-205739db168222
179185410 ML milrinone lactate 1 MG/ML InjectionSCD88f78780-399f-4780-be19-205739db168222
179185920 ML milrinone lactate 1 MG/ML InjectionSCD88f78780-399f-4780-be19-205739db168222
179186150 ML milrinone lactate 1 MG/ML InjectionSCD88f78780-399f-4780-be19-205739db168222
1791854milrinone lactate 10 MG per 10 ML InjectionSY88f78780-399f-4780-be19-205739db168222
1791859milrinone lactate 20 MG per 20 ML InjectionSY88f78780-399f-4780-be19-205739db168222
1791861milrinone lactate 50 MG per 50 ML InjectionSY88f78780-399f-4780-be19-205739db168222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9710-010014397100110 mL in 1 VIAL10 mlHistorical
0143-9710-100014397101010 VIAL in 1 BOX (0143-9710-10) / 10 mL in 1 VIAL (0143-9710-01) 10 vial2010-12-03NoNoCurrent
0143-9710-250014397102525 VIAL in 1 BOX (0143-9710-25) / 10 mL in 1 VIAL (0143-9710-01) 25 vial2010-12-030000-00-00NoNoCurrent