NDC Code(s) : 61786-207-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-207(NDC:0093-7115)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE ANHYDROUS(UNII: 3I3T11UD2S)
(PAROXETINE - UNII:41VRH5220H) 		PAROXETINE20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C RED NO. 40(UNII: WZB9127XOA)
POVIDONE K30(UNII: U725QWY32X)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
PIGMENT RED 5(UNII: 91OZU993LX)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color pink Score 2 pieces
Shape ROUND (TABLET, FILM COATED) Size 7 mm
Flavor Imprint Code 9;3;7115
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-207-0230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076618 03/03/2015

PRINCIPAL DISPLAY PANEL

DRUG: Paroxetine


GENERIC: Paroxetine Hydrochloride


DOSAGE: TABLET, FILM COATED


ADMINSTRATION: ORAL


NDC: 61786-207-02


ACTIVE INGREDIENT(S):

  • PAROXETINE HYDROCHLORIDE ANHYDROUS 20mg in 1


INACTIVE INGREDIENT(S):

  • CALCIUM PHOSPHATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • TITANIUM DIOXIDE
  • ALUMINUM OXIDE
  • FD&C RED NO. 40
  • POVIDONE K30
  • HYPROMELLOSE 2910 (3 MPA.S)
  • HYPROMELLOSE 2910 (6 MPA.S)
  • MAGNESIUM STEARATE
  • PIGMENT RED 5
  • POLYETHYLENE GLYCOL 400
  • POLYSORBATE 80


COLOR: pink


SHAPE: ROUND


SCORE: Two even pieces


SIZE: 7 mm


IMPRINT: 9;3;7115


PACKAGING: 30 in 1 BLISTER PACK




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