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.

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