Mirtazapine
Mirtazapine Tablets USP Revised: June 2008 Rx only
Approved
Approval ID
2373655d-ac74-43f5-a041-9f41a5b92206
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-086
Application NumberANDA076312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2011
FDA Product Classification
INGREDIENTS (10)
MIRTAZAPINEActive
Quantity: 15 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Mirtazapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-087
Application NumberANDA076312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2011
FDA Product Classification
INGREDIENTS (11)
MIRTAZAPINEActive
Quantity: 30 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT