Sertraline Hydrochloride (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-257(NDC:69097-833)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 25 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (Light Green) Score no score
Shape OVAL (modified, biconvex) Size 8mm
Flavor Imprint Code 212;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-257-15 15 TABLET in 1 BOTTLE None
2 NDC:53217-257-30 30 TABLET in 1 BOTTLE None
3 NDC:53217-257-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 07/21/2016
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 03/2017 Aidarex Pharmaceuticals LLC

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