Sertraline Hydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SERTRALINE 100MG
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SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-0961(NDC:31722-214)
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE 2910 (6 MPA.S)
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color yellow (Light Yellow) Score no score
Shape OVAL (modified, biconvex) Size 13mm
Flavor Imprint Code 214;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-0961-1 14 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 — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-0961), relabel (67296-0961)

Revised: 01/2020 RedPharm Drug, Inc.

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