Mirtazapine
Mirtazapine Tablets, USP
Approved
Approval ID
18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 3
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 Code21695-083
Application NumberANDA076921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2009
FDA Product Classification
INGREDIENTS (9)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MIRTAZAPINEActive
Quantity: 45 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Mirtazapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-081
Application NumberANDA076921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2009
FDA Product Classification
INGREDIENTS (10)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MIRTAZAPINEActive
Quantity: 15 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
Mirtazapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-082
Application NumberANDA076921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2009
FDA Product Classification
INGREDIENTS (12)
MIRTAZAPINEActive
Quantity: 30 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT