FDA.reportPublic FDA data

Milrinone Lactate in Dextrose

Product NDC
0409-1983
11-digit product format
004091983
Labeler code
0409
Product ID
0409-1983_41afad76-bea1-46c5-ab31-84a54b157410
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate in Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA213585
Marketing category
ANDA
Marketing start
2021-10-04
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Milrinone Lactate in Dextrose
Listing expiration
2026-12-31

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
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1983-01Milrinone Lactate in Dextrose200 mL in 1 BAGINJECTION, SOLUTION2002
0409-1983-01Milrinone Lactate in Dextrose1 in 1 POUCHINJECTION, SOLUTION12
0409-1983-10Milrinone Lactate in Dextrose10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1983-01ML - Milliliter0409-1983016e55dc-ca9b-4585-9e50-81028d8d36b212021-11-09
0409-1983-10ML - Milliliter0409-1983414d3187-71ff-4ac0-b946-d7712118199f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1983MILRINONE LACTATE IN DEXTROSE INJECTION, SOLUTION [HOSPIRA, INC.]2Current NDC, Legacy NDC, 3 package rows20220404_5273ea17-6920-4bff-8c5b-20ea531a0423.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791840milrinone lactate 20 MG in 100 ML InjectionPSN5273ea17-6920-4bff-8c5b-20ea531a04232
1791842milrinone lactate 40 MG in 200 ML InjectionPSN5273ea17-6920-4bff-8c5b-20ea531a04232
1791840100 ML milrinone lactate 0.2 MG/ML InjectionSCD5273ea17-6920-4bff-8c5b-20ea531a04232
1791842200 ML milrinone lactate 0.2 MG/ML InjectionSCD5273ea17-6920-4bff-8c5b-20ea531a04232
1791840milrinone lactate 20 MG per 100 ML InjectionSY5273ea17-6920-4bff-8c5b-20ea531a04232
1791842milrinone lactate 40 MG per 200 ML InjectionSY5273ea17-6920-4bff-8c5b-20ea531a04232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1983-0100409198301200 mL in 1 BAG200 mlHistorical
0409-1983-100040919831010 POUCH in 1 CARTON (0409-1983-10) / 1 BAG in 1 POUCH (0409-1983-01) / 200 mL in 1 BAG10 pouch2021-10-040000-00-00NoNoCurrent