MIRTAZAPINE tablet, orally disintegrating

Mirtazapine by

Drug Labeling and Warnings

Mirtazapine by is a Prescription medication manufactured, distributed, or labeled by SQUARE PHARMACEUTICALS LIMITED, SQUARE PHARMACEUTICALS LIMITED, Dhaka unit. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

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

INGREDIENTS AND APPEARANCE

MIRTAZAPINE 
mirtazapine tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76483-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)	MIRTAZAPINE	15 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white to off-white)	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	677
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76483-110-00	30 in 1 CARTON; Type 0: Not a Combination Product	11/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA205798	11/15/2022

MIRTAZAPINE 
mirtazapine tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76483-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)	MIRTAZAPINE	30 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white to off-white)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	676
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76483-111-00	30 in 1 CARTON; Type 0: Not a Combination Product	11/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA205798	11/15/2022

MIRTAZAPINE 
mirtazapine tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76483-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)	MIRTAZAPINE	45 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white to off-white)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	679
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76483-112-00	30 in 1 CARTON; Type 0: Not a Combination Product	11/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA205798	11/15/2022

Labeler - SQUARE PHARMACEUTICALS LIMITED (731487153)

Registrant - SQUARE PHARMACEUTICALS LIMITED (731487153)

Establishment
Name	Address	ID/FEI	Business Operations
SQUARE PHARMACEUTICALS LIMITED, Dhaka unit		850366520	ANALYSIS(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)