Sertraline (Page 14 of 14)

PRINCIPAL DISPLAY PANEL

Sertraline Tablets, USP
50 mg/90 TabletsNDC 64205-965-90

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(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Sertraline Tablets, USP
50 mg/30 TabletsNDC 64205-965-30

photo 2
(click image for full-size original)
SERTRALINE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64205-965(NDC:0143-9655)
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FD&C BLUE NO. 2
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color BLUE (light blue) Score 2 pieces
Shape OVAL (biconvex) Size 12mm
Flavor Imprint Code I;G;213
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64205-965-30 30 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE None
2 NDC:64205-965-90 90 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077864 11/06/2012
Labeler — ReadyMeds (072115132)
Establishment
Name Address ID/FEI Operations
ReadyMeds 072115132 repack (64205-965)

Revised: 05/2014 ReadyMeds

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