Duloxetine hydrochloride

FDA Drug Profile — Cymbalta

Duloxetine hydrochloride is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand name including Cymbalta. Available dosage forms: capsule, delayed release, powder.

Drug Details

Generic Name
Duloxetine hydrochloride
Brand Names
Cymbalta
Application Number
NDA021427
Sponsor
Lilly del Caribe, Inc.
NDC Codes
11
Dosage Forms
CAPSULE, DELAYED RELEASE, POWDER
Routes
ORAL
Active Ingredients
DULOXETINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Duloxetine delayed-release capsules is indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) Diabetic peripheral neuropathic pain (DPNP) in adults ( 1 ) Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older ( 1 ) Chronic musculoskeletal pain in adults ( 1 )