Label: MIRTAZAPINE tablet, orally disintegrating
- NDC Code(s): 76483-110-00, 76483-111-00, 76483-112-00
- Packager: SQUARE PHARMACEUTICALS LIMITED
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 disintegratingProduct 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 disintegratingProduct 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 disintegratingProduct 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)