REMERON
REMERON (mirtazapine)Tablets
Approved
Approval ID
8feda54f-a3fa-4108-bfc4-c15b0eab4396
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MIRTAZAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4498
Application NumberNDA020415
Product Classification
M
Marketing Category
C73594
G
Generic Name
MIRTAZAPINE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2012
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MIRTAZAPINEActive
Quantity: 30 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MIRTAZAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4848
Application NumberNDA020415
Product Classification
M
Marketing Category
C73594
G
Generic Name
MIRTAZAPINE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2012
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MIRTAZAPINEActive
Quantity: 15 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT