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Mirtazapine Orally Disintegrating Tablets

Package insert / prescribing information
Dosage form: tablet, orally disintegrating
Drug class: Tetracyclic antidepressants

Medically reviewed by Drugs.com. Last updated on Nov 1, 2022.

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

MIRTAZAPINE
mirtazapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76483-110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 15 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
POVIDONE K30
ASPARTAME
ALPHA-TOCOPHEROL
MALTODEXTRIN
SILICON DIOXIDE
ANHYDROUS CITRIC ACID
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
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
1 NDC:76483-110-00 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON
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 LABEL Item Code (Source) NDC:76483-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 30 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
POVIDONE K30
ASPARTAME
ALPHA-TOCOPHEROL
MALTODEXTRIN
SILICON DIOXIDE
ANHYDROUS CITRIC ACID
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
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
1 NDC:76483-111-00 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON
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 LABEL Item Code (Source) NDC:76483-112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 45 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE
POVIDONE K30
ASPARTAME
ALPHA-TOCOPHEROL
MALTODEXTRIN
SILICON DIOXIDE
ANHYDROUS CITRIC ACID
MAGNESIUM STEARATE
SODIUM STEARYL FUMARATE
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
1 NDC:76483-112-00 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON
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 Operations
SQUARE PHARMACEUTICALS LIMITED 731487153 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)
SQUARE PHARMACEUTICALS LIMITED