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NDC 00615-8495-39 Duloxetine 30 mg/1 Details

Duloxetine 30 mg/1

Duloxetine is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by NCS HealthCare of KY, LLC dba Vangard Labs. The primary component is DULOXETINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Duloxetine is used to treat depression in adults and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer) in adults and children 7 years of age and older. Duloxetine is also used to treat pain and tingling caused by diabetic neuropathy (damage to nerves that can develop in people who have diabetes) in adults and fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep) in adults and children 13 years of age and older. It is also used to treat ongoing bone or muscle pain such as lower back pain or osteoarthritis (joint pain or stiffness that may worsen over time) in adults. Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance and stop the movement of pain signals in the brain.

Related Packages: 00615-8495-39
Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Duloxetine

Product Information

NDC	00615-8495
Product ID	0615-8495_556bdb20-19a9-49b0-9c5b-6cd6e56465e1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Duloxetine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Duloxetine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/1
Substance Name	DULOXETINE HYDROCHLORIDE
Labeler Name	NCS HealthCare of KY, LLC dba Vangard Labs
Pharmaceutical Class	Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090694
Listing Certified Through	2025-12-31

Package

NDC 00615-8495-39 (00615849539)

Pricing Information	N/A
NDC Package Code	0615-8495-39
Billing NDC	00615849539
Package	30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8495-39)
Marketing Start Date	2024-01-03
NDC Exclude Flag	N