Sertraline Hydrochloride (Page 11 of 11)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 100 mg

Sertraline Hydrochloride
Tablets USP 100 mg*
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY.
100 Tablets

72789092 LABEL-
(click image for full-size original)

SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-092(NDC:16714-613)
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
DIBASIC CALCIUM PHOSPHATE 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:72789-092-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:72789-092-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:72789-092-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077206 02/06/2007
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-092)

Revised: 01/2023 PD-Rx Pharmaceuticals, Inc.

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