Sertraline (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

SERTRALINE 50MG
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SERTRALINE sertraline tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1199(NDC:68180-352)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 2
HYPROMELLOSES
SODIUM STARCH GLYCOLATE TYPE A POTATO
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE (capsule shaped, biconvex) Size 10mm
Flavor Imprint Code L;U;D02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1199-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077670 02/06/2007
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-1199)

Revised: 01/2022 RedPharm Drug, Inc.

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