MIRTAZAPINE- mirtazapine tablet, orally disintegrating 
SQUARE PHARMACEUTICALS LIMITED

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MIRTAZAPINE ORALLY DISINTEGRATING TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76483-110-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets

Mirtazapine Orally Disintegrating Tablets USP, 15 mg

Rx only

30 Tablets

Mirtazapine Orally Disintegrating Tablets USP, 15 mg

NDC 76483-111-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets

Mirtazapine Orally Disintegrating Tablets USP, 30 mg

Rx only

30 Tablets

Mirtazapine Orally Disintegrating Tablets USP, 30 mg

NDC 76483-112-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets

Mirtazapine Orally Disintegrating Tablets USP, 45 mg

Rx only

30 Tablets

Mirtazapine Orally Disintegrating Tablets USP, 45 mg
MIRTAZAPINE 
mirtazapine tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q) MIRTAZAPINE15 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
POVIDONE K30 (UNII: U725QWY32X)  
ASPARTAME (UNII: Z0H242BBR1)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code 677
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76483-110-0030 in 1 CARTON; Type 0: Not a Combination Product11/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20579811/15/2022
MIRTAZAPINE 
mirtazapine tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q) MIRTAZAPINE30 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
POVIDONE K30 (UNII: U725QWY32X)  
ASPARTAME (UNII: Z0H242BBR1)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 676
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76483-111-0030 in 1 CARTON; Type 0: Not a Combination Product11/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20579811/15/2022
MIRTAZAPINE 
mirtazapine tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q) MIRTAZAPINE45 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
POVIDONE K30 (UNII: U725QWY32X)  
ASPARTAME (UNII: Z0H242BBR1)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 679
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76483-112-0030 in 1 CARTON; Type 0: Not a Combination Product11/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20579811/15/2022
Labeler - SQUARE PHARMACEUTICALS LIMITED (731487153)
Registrant - SQUARE PHARMACEUTICALS LIMITED (731487153)
Establishment
NameAddressID/FEIBusiness Operations
SQUARE PHARMACEUTICALS LIMITED, Dhaka unit850366520ANALYSIS(76483-110, 76483-111, 76483-112) , LABEL(76483-110, 76483-111, 76483-112) , MANUFACTURE(76483-110, 76483-111, 76483-112) , PACK(76483-110, 76483-111, 76483-112)

Revised: 7/2023
Document Id: d6b98cf3-2e20-47c1-bb31-e8dd31f67cdf
Set id: 83093852-d212-408e-98fd-33f4603a9d65
Version: 3
Effective Time: 20230702
 
SQUARE PHARMACEUTICALS LIMITED