Duloxetine Hydrochloride (Page 16 of 16)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Duloxetine DR Caps 20 mg
(click image for full-size original)
DULOXETINE HYDROCHLORIDE duloxetin hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8290(NDC:13668-109)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
GELATIN
HYPROMELLOSE 2910 (6 MPA.S)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL 400
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color BLUE (light blue cap and body) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 20;mg;1109
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8290-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090774 12/11/2013
Labeler — NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK (0615-8290)

Revised: 06/2019 NCS HealthCare of KY, Inc dba Vangard Labs

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