FDA.reportPublic FDA data

Milrinone Lactate

Product NDC
71288-200
11-digit product format
712880200
Labeler code
71288
Product ID
71288-200_9fb02532-b43c-40c3-adf1-f5071a415e05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211671
Marketing category
ANDA
Marketing start
2020-03-24
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
71288-200-10Milrinone Lactate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION104
71288-200-11Milrinone Lactate10 in 1 CARTONINJECTION, SOLUTION104
71288-200-20Milrinone Lactate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION204
71288-200-21Milrinone Lactate10 in 1 CARTONINJECTION, SOLUTION104
71288-200-50Milrinone Lactate50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION504
71288-200-50Milrinone Lactate1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-200-10ML - Milliliter71288-20064e4e36f-0f0d-4e14-adc6-fbf0ab91f5d512020-08-06
71288-200-11ML - Milliliter71288-2003f1dbe1a-d4c2-4873-8cc0-964a7572b26912020-08-06
71288-200-20ML - Milliliter71288-200d65c89bb-d166-46dd-927f-a618323e6e7812020-08-06
71288-200-21ML - Milliliter71288-2005fb82783-a3f8-4882-b9f0-9cc68121ef6012020-08-06
71288-200-50ML - Milliliter71288-2006505f363-1f57-4c2b-a3bb-fcc5eefc48fb12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-200MILRINONE LACTATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 6 package rows20220115_6c6b69f9-e229-4a93-a108-9eafdab614f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791854milrinone lactate 10 MG in 10 ML InjectionPSN6c6b69f9-e229-4a93-a108-9eafdab614f04
1791859milrinone lactate 20 MG in 20 ML InjectionPSN6c6b69f9-e229-4a93-a108-9eafdab614f04
1791861milrinone lactate 50 MG in 50 ML InjectionPSN6c6b69f9-e229-4a93-a108-9eafdab614f04
179185410 ML milrinone lactate 1 MG/ML InjectionSCD6c6b69f9-e229-4a93-a108-9eafdab614f04
179185920 ML milrinone lactate 1 MG/ML InjectionSCD6c6b69f9-e229-4a93-a108-9eafdab614f04
179186150 ML milrinone lactate 1 MG/ML InjectionSCD6c6b69f9-e229-4a93-a108-9eafdab614f04
1791854milrinone lactate 10 MG per 10 ML InjectionSY6c6b69f9-e229-4a93-a108-9eafdab614f04
1791859milrinone lactate 20 MG per 20 ML InjectionSY6c6b69f9-e229-4a93-a108-9eafdab614f04
1791861milrinone lactate 50 MG per 50 ML InjectionSY6c6b69f9-e229-4a93-a108-9eafdab614f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-200-107128802001010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
71288-200-117128802001110 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-200-10) 2020-03-240000-00-00NoNoCurrent
71288-200-207128802002020 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
71288-200-217128802002110 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-200-20) 2020-03-240000-00-00NoNoCurrent
71288-200-50712880200501 VIAL, SINGLE-DOSE in 1 CARTON (71288-200-50) / 50 mL in 1 VIAL, SINGLE-DOSE2020-03-240000-00-00NoNoCurrent