FDA label
What is duloxetine used for?
The FDA-approved uses of duloxetine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Duloxetine delayed-release capsules are 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.”
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Duloxetine, capsule, delayed release
Indications and Usage, quoted from the label by Lupin Pharmaceuticals, Inc. (ANDA090694). Cross-references to other label sections are left out.
Duloxetine delayed-release capsules are 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
Source: DailyMed label, set id 829a4f51-c882-4b64-81f3-abfb03a52ebe, version 26, effective May 20, 2026. NDC 68180-294, one of 143 listings for this product.
Duloxetine Hydrochloride, capsule, delayed release pellets
Indications and Usage, quoted from the label by Yaopharma Co., Ltd. (ANDA207219). Cross-references to other label sections are left out.
Duloxetine delayed-release capsules, USP are indicated for the treatment of:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Diabetic Peripheral Neuropathy
- Chronic Musculoskeletal Pain
Source: DailyMed label, set id 90224073-178d-7ec5-e053-2995a90a20fc, version 12, effective July 7, 2026. NDC 50771-201, one of 55 listings for this product.
Questions
What is duloxetine used for?
The FDA label says: “Duloxetine delayed-release capsules are 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.”
What drug class is duloxetine?
FDA lists duloxetine in the Serotonin and Norepinephrine Reuptake Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Duloxetine
- Is Duloxetine a controlled substance?Federal schedule
- Generic for CymbaltaFDA Orange Book
- Generic for Drizalma SprinkleFDA Orange Book
- Serotonin and Norepinephrine Reuptake Inhibitors listFDA drug class
- Duloxetine Medicare Part D coverageBy plan and state
- NDC 47335-616Duloxetine NDC record
- NDC 47335-617Duloxetine NDC record
- NDC 47335-618Duloxetine NDC record