Mirtazapine
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS
Approved
Approval ID
83093852-d212-408e-98fd-33f4603a9d65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2023
Manufacturers
FDA
SQUARE PHARMACEUTICALS LIMITED
DUNS: 731487153
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 Code76483-110
Application NumberANDA205798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2023
FDA Product Classification
INGREDIENTS (12)
MIRTAZAPINEActive
Quantity: 15 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Mirtazapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76483-111
Application NumberANDA205798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2023
FDA Product Classification
INGREDIENTS (12)
MIRTAZAPINEActive
Quantity: 30 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Mirtazapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76483-112
Application NumberANDA205798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mirtazapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2023
FDA Product Classification
INGREDIENTS (12)
MIRTAZAPINEActive
Quantity: 45 mg in 1 1
Code: A051Q2099Q
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/23/2022