FDA.reportPublic FDA data

Milrinone Lactate in Dextrose

Product NDC
0338-6010
11-digit product format
003386010
Labeler code
0338
Product ID
0338-6010_cb4ae76f-1612-4595-a984-a62c60062268
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MILRINONE LACTATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA075834
Marketing category
ANDA
Marketing start
2002-05-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
0338-6010-48Milrinone Lactate in Dextrose10 in 1 CARTONINJECTION, SOLUTION1016
0338-6010-48Milrinone Lactate in Dextrose100 mL in 1 BAGINJECTION, SOLUTION10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-6010-48ML - Milliliter0338-6010e9da96d6-95c9-4543-993f-6efaab06c6c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MILRINONE LACTATEACTIVE INGREDIENT9K8XR81MO8MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
MILRINONEACTIVE MOIETYJU9YAX04C7MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GMILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
WATERINACTIVE INGREDIENT059QF0KO0RMILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-6010MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 2 package rows20250519_8fd0f93a-6150-4020-b7ee-4b95b520f6ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791840milrinone lactate 20 MG in 100 ML InjectionPSN8fd0f93a-6150-4020-b7ee-4b95b520f6ce16
1791842milrinone lactate 40 MG in 200 ML InjectionPSN8fd0f93a-6150-4020-b7ee-4b95b520f6ce16
1791840100 ML milrinone lactate 0.2 MG/ML InjectionSCD8fd0f93a-6150-4020-b7ee-4b95b520f6ce16
1791842200 ML milrinone lactate 0.2 MG/ML InjectionSCD8fd0f93a-6150-4020-b7ee-4b95b520f6ce16
1791840milrinone lactate 20 MG per 100 ML InjectionSY8fd0f93a-6150-4020-b7ee-4b95b520f6ce16
1791842milrinone lactate 40 MG per 200 ML InjectionSY8fd0f93a-6150-4020-b7ee-4b95b520f6ce16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-6010-480033860104810 BAG in 1 CARTON (0338-6010-48) / 100 mL in 1 BAG10 bag2002-05-280000-00-00NoNoCurrent