NDC 62037-754-10
API & Excipient Details

Mirtazapine marketed by Actavis Pharma, Inc. under NDC Code 62037-754-10

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62037-753-30	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	20/06/2003
2	NDC:62037-753-10	1000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	20/06/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62037-754-30	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	20/06/2003
2	NDC:62037-754-10	1000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	20/06/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62037-755-30	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	20/06/2003
2	NDC:62037-755-10	1000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	20/06/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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