NDC Code(s) : 0093-7303-18, 0093-7303-65, 0093-7304-18, 0093-7304-65, 0093-7305-02, 0093-7305-65
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MirtazapineMirtazapine TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7303
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE(UNII: A051Q2099Q)
(MIRTAZAPINE - UNII:A051Q2099Q) 		MIRTAZAPINE15 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
ORANGE OIL(UNII: AKN3KSD11B)
ORANGE JUICE(UNII: 5A9KE2L9L3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CASSAVA(UNII: MAO53YB5PV)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 8 mm
Flavor ORANGE Imprint Code 93;7303
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-7303-6530 in 1 BOX 01/09/2005
1NDC:0093-7303-181 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076901 09/01/2005 03/31/2018
MirtazapineMirtazapine TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7304
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE(UNII: A051Q2099Q)
(MIRTAZAPINE - UNII:A051Q2099Q) 		MIRTAZAPINE30 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
ORANGE OIL(UNII: AKN3KSD11B)
ORANGE JUICE(UNII: 5A9KE2L9L3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CASSAVA(UNII: MAO53YB5PV)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 10 mm
Flavor ORANGE Imprint Code 93;7304
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-7304-6530 in 1 BOX 01/09/2005
1NDC:0093-7304-181 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076901 09/01/2005 03/31/2018
MirtazapineMirtazapine TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7305
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE(UNII: A051Q2099Q)
(MIRTAZAPINE - UNII:A051Q2099Q) 		MIRTAZAPINE45 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
ORANGE OIL(UNII: AKN3KSD11B)
ORANGE JUICE(UNII: 5A9KE2L9L3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CASSAVA(UNII: MAO53YB5PV)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 12 mm
Flavor ORANGE Imprint Code 93;7305
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-7305-6530 in 1 BOX 01/09/2005
1NDC:0093-7305-021 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076901 09/01/2005 05/31/2018

PRINCIPAL DISPLAY PANEL

Mirtazapine Orally Disintegrating Tablets USP 15 mg 30s Box

PRINCIPAL DISPLAY PANEL

Mirtazapine Orally Disintegrating Tablets USP 30 mg 30s Box

PRINCIPAL DISPLAY PANEL

Mirtazapine Orally Disintegrating Tablets USP 45 mg 30s Box