NDC Code(s) : 62037-753-30, 62037-753-10, 62037-754-30, 62037-754-10, 62037-755-30, 62037-755-10
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MirtazapineMirtazapine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-753
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW (light yellow) Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code 753
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-753-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/06/2003
2NDC:62037-753-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/06/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076336 06/20/2003 09/12/2008
MirtazapineMirtazapine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-754
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code 754
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-754-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/06/2003
2NDC:62037-754-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/06/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076336 06/20/2003 10/17/2008
MirtazapineMirtazapine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-755
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code 755
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-755-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/06/2003
2NDC:62037-755-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/06/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076336 06/20/2003 07/31/2008

PRINCIPAL DISPLAY PANEL

Mirtazapine Tablets USP 15 mg, 30s Label

PRINCIPAL DISPLAY PANEL

Mirtazapine Tablets USP 30 mg, 30s Label

PRINCIPAL DISPLAY PANEL

Mirtazapine Tablets USP 45 mg, 30s Label