FDA.reportPublic FDA data

Milrinone Lactate

Product NDC
63323-617
11-digit product format
633230617
Labeler code
63323
Product ID
63323-617_7ada1876-c47a-4e3e-bd48-a6a1f486b517
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MILRINONE LACTATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075936
Marketing category
ANDA
Marketing start
2002-08-01
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
63323-617-01Milrinone Lactate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
63323-617-02Milrinone Lactate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION206
63323-617-10Milrinone Lactate10 in 1 TRAYINJECTION, SOLUTION106
63323-617-20Milrinone Lactate10 in 1 TRAYINJECTION, SOLUTION106
63323-617-50Milrinone Lactate50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION506
63323-617-50Milrinone Lactate1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-617-01ML - Milliliter63323-6170164d2fb-de7f-4c87-b54e-11fc54147a5c12025-10-14
63323-617-02ML - Milliliter63323-617c6fd8e0d-3eb0-4bee-9750-5b5ba37ca75812025-07-08
63323-617-10ML - Milliliter63323-61712c104a6-1d54-406c-8c8c-3fdc9afb4b6812013-02-13
63323-617-20ML - Milliliter63323-617a4d179e4-e0ad-4534-875a-9cc80d9f3e8712013-02-13
63323-617-50ML - Milliliter63323-617a67f1b90-71ee-4f8f-b4eb-e491aee4bdf412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MILRINONE LACTATEACTIVE INGREDIENT9K8XR81MO8MILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
MILRINONEACTIVE MOIETYJU9YAX04C7MILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKMILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-617MILRINONE LACTATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 6 package rows20230406_ac43ba6b-635d-4129-8eea-96f3f5a4785e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791854milrinone lactate 10 MG in 10 ML InjectionPSNac43ba6b-635d-4129-8eea-96f3f5a4785e6
1791859milrinone lactate 20 MG in 20 ML InjectionPSNac43ba6b-635d-4129-8eea-96f3f5a4785e6
1791861milrinone lactate 50 MG in 50 ML InjectionPSNac43ba6b-635d-4129-8eea-96f3f5a4785e6
179185410 ML milrinone lactate 1 MG/ML InjectionSCDac43ba6b-635d-4129-8eea-96f3f5a4785e6
179185920 ML milrinone lactate 1 MG/ML InjectionSCDac43ba6b-635d-4129-8eea-96f3f5a4785e6
179186150 ML milrinone lactate 1 MG/ML InjectionSCDac43ba6b-635d-4129-8eea-96f3f5a4785e6
1791854milrinone lactate 10 MG per 10 ML InjectionSYac43ba6b-635d-4129-8eea-96f3f5a4785e6
1791859milrinone lactate 20 MG per 20 ML InjectionSYac43ba6b-635d-4129-8eea-96f3f5a4785e6
1791861milrinone lactate 50 MG per 50 ML InjectionSYac43ba6b-635d-4129-8eea-96f3f5a4785e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-617-016332306170110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-617-026332306170220 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-617-106332306171010 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-617-01) 2002-08-010000-00-00NoNoCurrent
63323-617-206332306172010 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-617-02) 2002-08-010000-00-00NoNoCurrent
63323-617-50633230617501 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50) / 50 mL in 1 VIAL, SINGLE-DOSE2002-08-010000-00-00NoNoCurrent