NDC Code(s) : 61786-603-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PEXEVAparoxetine mesylate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-603(NDC:68968-2010)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE MESYLATE(UNII: M711N184JE)
(PAROXETINE - UNII:41VRH5220H) 		PAROXETINE10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white) Score no score
Shape OVAL (OVAL) Size 4 mm
Flavor Imprint Code 10mg;POT10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-603-0230 in 1 BLISTER PACK Type 0: Not a Combination Product23/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021299 02/23/2016

PRINCIPAL DISPLAY PANEL

DRUG: PEXEVA

GENERIC: paroxetine mesylate

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-603-02

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 4 mm

IMPRINT: 10mg;POT10

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • PAROXETINE MESYLATE 10mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE
  • MAGNESIUM STEARATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • HYDROXYPROPYL CELLULOSE
  • HYPROMELLOSE 2910 (50 MPA.S)
  • TITANIUM DIOXIDE

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