Mirtazapine
Mirtazapine Tablets, USP
Approved
Approval ID
34c0b734-98ca-4aec-965f-e55edd3317f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0482
Application NumberANDA077666
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2010
FDA Product Classification
INGREDIENTS (15)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MIRTAZAPINEActive
Quantity: 15 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Mirtazapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0483
Application NumberANDA077666
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2010
FDA Product Classification
INGREDIENTS (14)
MIRTAZAPINEActive
Quantity: 30 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Mirtazapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0484
Application NumberANDA077666
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2010
FDA Product Classification
INGREDIENTS (14)
MIRTAZAPINEActive
Quantity: 45 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT