Milnacipran HCl

Product NDC
65162-093
11-digit product format
651620093
Labeler code
65162
Product ID
65162-093_ba8b4064-0e7b-4ace-863f-764584d538cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Milnacipran HCl
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205081
Marketing category
ANDA
Marketing start
2014-01-31
Marketing end
0000-00-00
Substance
MILNACIPRAN HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7a197179-317f-1516-8da2-c7f3df29602aProduct name420250423

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-093MILNACIPRAN HCL TABLET [AMNEAL PHARMACEUTICALS LLC]15Legacy NDC20240805_eaa14195-1b9c-423c-9412-d2fe0857e39d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-093-066516200930660 TABLET in 1 BOTTLE (65162-093-06) 60 tablet2014-01-310000-00-00NoNoCurrent
65162-093-5065162009350500 TABLET in 1 BOTTLE (65162-093-50) 500 tablet2014-01-310000-00-00NoNoCurrent