Sertraline Hydrochloride (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 50mg — 60 count

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SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-518(NDC:31722-213)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 50 mg
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
FD&C BLUE NO. 2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE
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
Product Characteristics
Color blue (Light Blue) Score no score
Shape OVAL (modified, biconvex) Size 10mm
Flavor Imprint Code 213;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-518-30 30 TABLET in 1 BOTTLE None
2 NDC:45865-518-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 10/18/2007
Labeler — Medsource Pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
Medsource Pharmaceuticals 833685915 repack (45865-518)

Revised: 12/2019 Medsource Pharmaceuticals

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