Mirtazapine
These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
979eec8b-1bf4-466b-812e-85a111ce1cb5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2025
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mirtazapine
PRODUCT DETAILS
NDC Product Code72603-558
Application NumberANDA076921
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 24, 2025
Generic NameMirtazapine
INGREDIENTS (9)
MIRTAZAPINEActive
Quantity: 7.5 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT