Sertraline Hydrochloride (Page 9 of 9)

PACKAGE LABEL

Label Image for 53808-1127 100mg

Label Image for 100mgLabel Image for 100mg
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1127(NDC:65862-013)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE (Biconvex) Size 13mm
Flavor Imprint Code A;1;8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-1127-1 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077206 09/04/2018
Labeler — DOH CENTRAL PHARMACY (829348114)
Establishment
Name Address ID/FEI Operations
DOH CENTRAL PHARMACY 829348114 repack (53808-1127)

Revised: 01/2019 DOH CENTRAL PHARMACY

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