NDC Code(s) : 61786-518-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SertralineSertraline TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-518(NDC:68180-353)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE(UNII: UTI8907Y6X)
(SERTRALINE - UNII:QUC7NX6WMB) 		SERTRALINE100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow Score 2 pieces
Shape CAPSULE (capsule shaped, biconvex) Size 13 mm
Flavor Imprint Code L;U;D03
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-518-0230 in 1 BLISTER PACK Type 0: Not a Combination Product24/12/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077670 12/24/2015 01/23/2017

PRINCIPAL DISPLAY PANEL

DRUG: Sertraline

GENERIC: Sertraline

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-518-02

COLOR: yellow

SHAPE: CAPSULE

SCORE: Two even pieces

SIZE: 13 mm

IMPRINT: L;U;D03

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • SERTRALINE HYDROCHLORIDE 100mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE
  • MAGNESIUM STEARATE
  • HYDROXYPROPYL CELLULOSE (TYPE H)
  • POLYETHYLENE GLYCOLS
  • POLYSORBATE 80
  • CELLULOSE, MICROCRYSTALLINE
  • FERRIC OXIDE YELLOW
  • HYPROMELLOSES
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • TITANIUM DIOXIDE

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