Duloxetine


Duloxetine delayed-release capsules USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules USP was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1)].

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.


Duloxetine delayed-release capsules USP are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine delayed-release capsules USP was established in three short-term trials and one maintenance trial in adults [see Clinical Studies (14.2)].
 Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.

Duloxetine delayed-release capsules USP are indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies (14.3)].

Duloxetine Description


Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-?-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOS•HCl, which corresponds to a molecular weight of 333.88. The structural formula is:



Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. 

Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg).

For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.
 For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water.

Duloxetine Reviews

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Active Duloxetine Ingredients

  1. Duloxetine Hydrochloride

Duloxetine NDC Codes

NDC Quantity Package
47335-0381-83 30 1 Bottle
47335-0381-86 60 1 Bottle
47335-0381-88 100 1 Bottle
47335-0381-08 100 1 Bottle
47335-0381-18 1000 1 Bottle
47335-0381-61 100 1 Carton
47335-0382-83 30 1 Bottle
47335-0382-81 90 1 Bottle
47335-0382-88 100 1 Bottle
47335-0382-08 100 1 Bottle
47335-0382-18 1000 1 Bottle
47335-0382-61 100 1 Carton
47335-0383-83 30 1 Bottle
47335-0383-88 100 1 Bottle
47335-0383-08 100 1 Bottle
47335-0383-18 1000 1 Bottle
47335-0383-61 100 1 Carton
00093-7542-06 60 1 Bottle
00093-7543-56 30 1 Bottle
00093-7543-98 90 1 Bottle
00093-7544-56 30 1 Bottle
00093-7544-10 1000 1 Bottle
57237-0017-60 60 1 Bottle
57237-0018-30 30 1 Bottle
57237-0018-90 90 1 Bottle
57237-0018-99 1000 1 Bottle
57237-0019-30 30 1 Bottle
57237-0019-90 90 1 Bottle
57237-0019-99 1000 1 Bottle
68180-0294-06 30 1 Bottle
68180-0294-09 90 1 Bottle
68180-0294-03 1000 1 Bottle
68180-0294-07 60 1 Bottle
68180-0295-06 30 1 Bottle
68180-0295-09 90 1 Bottle
68180-0295-03 1000 1 Bottle
68180-0296-06 30 1 Bottle
68180-0296-09 90 1 Bottle
68180-0296-03 1000 1 Bottle
00228-2980-06 60 Capsule 1 Bottle
00228-2980-50 500 Capsule 1 Bottle
00228-2891-03 30 Capsule 1 Bottle
00228-2891-09 90 Capsule 1 Bottle
00228-2891-50 500 Capsule 1 Bottle
00228-2892-03 30 Capsule 1 Bottle
00228-2892-09 90 Capsule 1 Bottle
00228-2892-96 1000 Capsule 1 Bottle
00228-2890-06 60 Capsule 1 Bottle
00228-2890-50 500 Capsule 1 Bottle
68084-0675-11 1 1 Blister Pack
68084-0675-21 30 1 Box Unit Dose
68084-0683-11 1 1 Blister Pack
68084-0683-01 100 1 Box Unit Dose
68084-0692-11 1 1 Blister Pack
68084-0692-01 100 1 Box Unit Dose
00179-0144-70 30 1 Box Unit Dose
66993-0075-60 60 1 Bottle
66993-0076-30 30 1 Bottle
66993-0077-30 30 1 Bottle
52125-0817-02 30 Capsule 1 Blister Pack
52125-0818-02 30 Capsule 1 Blister Pack
68382-0241-06 30 1 Bottle
68382-0241-14 60 1 Bottle
68382-0241-16 90 1 Bottle
68382-0241-10 1000 1 Bottle
68382-0242-06 30 1 Bottle
68382-0242-16 90 1 Bottle
68382-0242-10 1000 1 Bottle
68382-0243-06 30 1 Bottle
68382-0243-16 90 1 Bottle
68382-0243-10 1000 1 Bottle
65841-0774-06 30 1 Bottle
65841-0774-14 60 1 Bottle
65841-0774-16 90 1 Bottle
65841-0774-10 1000 1 Bottle
65841-0775-06 30 1 Bottle
65841-0775-16 90 1 Bottle
65841-0775-10 1000 1 Bottle
65841-0776-06 30 1 Bottle
65841-0776-16 90 1 Bottle
65841-0776-10 1000 1 Bottle
68001-0255-06 60 1 Bottle
68001-0256-04 30 1 Bottle
68001-0256-05 90 1 Bottle
68001-0257-04 30 1 Bottle
68001-0257-08 1000 1 Bottle

Duloxetine Structured Product Labels

SPL Manufacturer
f16beb64-5878-486a-82ee-8e83e728f26c Sun Pharma Global FZE
82c59da6-d5bc-4f55-8d75-c6117854f34e Teva Pharmaceuticals USA Inc
ea2dc1a6-22d5-4295-9d39-9bf015dc5a89 Citron Pharma LLC
829a4f51-c882-4b64-81f3-abfb03a52ebe Lupin Pharmaceuticals, Inc.
9dab9154-b86f-40dc-a4d1-18e6534dbc78 Actavis Elizabeth LLC
4616f5fa-8e43-4a44-8484-f4dfd950a9b7 American Health Packaging
b60d673d-ba19-47ea-9147-fdae564a72dd KAISER FOUNDATION HOSPITALS
bb15bd15-b27e-4814-b4cf-7636f25c0792 Prasco Laboratories
71e79413-ac18-4e5c-9282-39669769f299 REMEDYREPACK INC.
359cb576-0345-4768-bcae-d57a170c5edd REMEDYREPACK INC.
9e20ba52-19bb-4683-b6ec-293b54f45898 Zydus Pharmaceuticals (USA) Inc.
5e7fad97-2e62-4f1c-92aa-ea1318c3db09 Cadila Healthcare Limited
99223cd0-6fc9-48ed-b36c-401069bb5bcd BluePoint Laboratories

Duloxetine Overview

Overall Rating
Medication Type
Prescription
Approval Date
Dec 11, 2013
DEA Schedule
Not Classified

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