FDA.reportPublic FDA data

Milrinone Lactate

Product NDC
68083-318
11-digit product format
680830318
Labeler code
68083
Product ID
68083-318_43fd392a-531d-4d69-917e-f19b16272d7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milrinone Lactate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA077190
Marketing category
ANDA
Marketing start
2017-07-28
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68083-318-102020-01-31C16284748780-19d75b9d0-07cf-f424-e053-dadaa90a57ceRx only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-318MILRINONE LACTATE INJECTION [GLAND PHARMA LIMITED]2Legacy NDC20170728_fa8c2d27-bb10-4966-bd8e-193fd921ea17.zip