FDA.reportPublic FDA data

Milrinone Lactate

Product NDC
0143-9374
11-digit product format
001439374
Labeler code
0143
Product ID
0143-9374_fc4d5027-2c9b-42fb-9c74-1d65b26319c0
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
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

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
0143-9374-01Milrinone Lactate20 mL in 1 VIALINJECTION, SOLUTION203
0143-9374-10Milrinone Lactate10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9374-01ML - Milliliter0143-9374e288569b-837f-4e60-ac7b-74dd65242e8312021-08-05
0143-9374-10ML - Milliliter0143-9374c3d78249-cfad-44fb-8778-c302bf6ecb1b12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9374MILRINONE LACTATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20231121_b3c936b3-5c86-4d87-9544-e94e95d0245f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791854milrinone lactate 10 MG in 10 ML InjectionPSNb3c936b3-5c86-4d87-9544-e94e95d0245f3
1791859milrinone lactate 20 MG in 20 ML InjectionPSNb3c936b3-5c86-4d87-9544-e94e95d0245f3
179185410 ML milrinone lactate 1 MG/ML InjectionSCDb3c936b3-5c86-4d87-9544-e94e95d0245f3
179185920 ML milrinone lactate 1 MG/ML InjectionSCDb3c936b3-5c86-4d87-9544-e94e95d0245f3
1791854milrinone lactate 10 MG per 10 ML InjectionSYb3c936b3-5c86-4d87-9544-e94e95d0245f3
1791859milrinone lactate 20 MG per 20 ML InjectionSYb3c936b3-5c86-4d87-9544-e94e95d0245f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9374-010014393740120 mL in 1 VIAL20 mlHistorical
0143-9374-100014393741010 VIAL in 1 CARTON (0143-9374-10) / 20 mL in 1 VIAL (0143-9374-01) 10 vial2010-12-030000-00-00NoNoCurrent