Prescription Drug Information: Sertraline Hydrochloride (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

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SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2767(NDC:16714-612)
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
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
FD&C BLUE NO. 2
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE (Biconvex) Size 10mm
Flavor Imprint Code A;1;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2767-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077206 02/06/2007
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-2767)

Revised: 06/2022 NuCare Pharmaceuticals,Inc.

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