Mirtazapine

Product NDC
50090-2558
11-digit product format
500902558
Labeler code
50090
Product ID
50090-2558_1227fedd-ff4c-4393-aa32-73ad0b8424b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
A051Q2099QMIRTAZAPINE85650-52-8MIRTAZAPINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-2558-05009025580030 TABLET, FILM COATED in 1 BOTTLE (50090-2558-0) 2017-03-13NoNoHistorical
50090-2558-25009025580260 TABLET, FILM COATED in 1 BOTTLE (50090-2558-2) 2016-12-16NoNoHistorical
50090-2558-35009025580390 TABLET, FILM COATED in 1 BOTTLE (50090-2558-3) 2016-10-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MirtazapineA-S Medication Solutions2026-02-12Human Prescription Drug Label27