NDC Code 0093-7115-98 - Paroxetine Hydrochloride

NDC Code(s) : 0093-7114-98, 0093-7115-98, 0093-7116-98, 0093-7121-98
Packager : Teva Pharmaceuticals USA Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ParoxetineParoxetine Hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-7114
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE ANHYDROUS(UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)	PAROXETINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALUMINUM OXIDE(UNII: LMI26O6933)

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	ROUND	Size	6 mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-7114-98	90 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076618	11/07/2005

ParoxetineParoxetine Hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-7115
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE ANHYDROUS(UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)	PAROXETINE	20 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALUMINUM OXIDE(UNII: LMI26O6933)
PIGMENT RED 5(UNII: 91OZU993LX)

Product Characteristics
Color	PINK	Score	2 pieces
Shape	ROUND	Size	7 mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-7115-98	90 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076618	10/03/2005

ParoxetineParoxetine Hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-7116
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE ANHYDROUS(UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)	PAROXETINE	30 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
ALUMINUM OXIDE(UNII: LMI26O6933)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	9 mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-7116-98	90 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076618	11/02/2005

ParoxetineParoxetine Hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0093-7121
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE ANHYDROUS(UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)	PAROXETINE	40 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN	Score	no score
Shape	ROUND	Size	9 mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0093-7121-98	90 in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076618	11/02/2005

NDC 0093-7115-98
API & Excipient Details

Paroxetine Hydrochloride marketed by Teva Pharmaceuticals USA Inc under NDC Code 0093-7115-98

NDC Code(s) : 0093-7114-98, 0093-7115-98, 0093-7116-98, 0093-7121-98
Packager : Teva Pharmaceuticals USA Inc

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0093-7115-98 API & Excipient Details

Paroxetine Hydrochloride marketed by Teva Pharmaceuticals USA Inc under NDC Code 0093-7115-98

NDC Code(s) : 0093-7114-98, 0093-7115-98, 0093-7116-98, 0093-7121-98Packager : Teva Pharmaceuticals USA Inc

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0093-7115-98
API & Excipient Details

NDC Code(s) : 0093-7114-98, 0093-7115-98, 0093-7116-98, 0093-7121-98
Packager : Teva Pharmaceuticals USA Inc