Duloxetine D/R 30 mg/1
Duloxetine D/R · CAPSULE, DELAYED RELEASE · Direct_Rx
Duloxetine is an oral delayed-release capsule used to treat depression, anxiety disorders, pain conditions, and other health problems. It works by affecting certain chemicals in the brain and is available in a 30 mg strength as a prescription medication.
Key Facts
- Brand Name
- Duloxetine D/R
- Generic Name
- Duloxetine D/R
- NDC Code (Product)
72189-661- Manufacturer
- Direct_Rx
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208706
- Marketing Start
- 02/09/2026
Recall History
Direct Rx
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Full Prescribing Information
Indications & Usage
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
Dosage & Administration
2.1 Important Administration Instructions Administer duloxetine delayed-release capsules orally (with or without meals) and swallow whole. Do not chew or crush, and do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. If a dose of duloxetine delayed-release capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time. 2.2 Dosage for Treatment of Major Depressive Disorder in Adults The recommended starting dosage in adults with MDD is 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to duloxetine delayed- release capsules before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. Periodically reassess to determine the need f…
Contraindications
The use of MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4)].
Drug Interactions
Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. 7.1 Inhibitors of CYP1A2 When duloxetine 60 mg was co-administered with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to male subjects (n=14) duloxetine AUC was increased approximately 6-fold, the Cmax was increased about 2.5-fold, and duloxetine t1/2 was increased approximately 3-fold. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin [see Warnings and Precautions (5.12)]. 7.2 Inhibitors of CYP2D6 Concomitant use of duloxetine (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions (5.12)]. 7.3 Dual Inhibition of CYP1A2 and CYP2D6 Concomitant administration of duloxetine 40 mg twice daily with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to CYP2D6 poor metabolizer subjects (n=14) resulted in a 6-fold increase in duloxetine AUC and Cmax. 7.4 Drugs that Interfere with Hemostasi…
Adverse Reactions
The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults [see Boxed Warning and Warnings And Precautions (5.1)] Hepatotoxicity [see Warnings And Precautions (5.2)] Orthostatic Hypotension, Falls and Syncope [see Warnings And Precautions (5.3)] Serotonin Syndrome [see Warnings And Precautions (5.4)] Abnormal Bleeding [see Warnings And Precautions (5.5)] Severe Skin Reactions [see Warnings And Precautions (5.6)] Discontinuation of Treatment with duloxetine [see Warnings And Precautions (5.7)] Activation of Mania/Hypomania [see Warnings And Precautions (5.8)] Angle-Closure Glaucoma [see Warnings And Precautions (5.9)] Seizures [see Warnings And Precautions (5.10)] Effect on Blood Pressure [see Warnings And Precautions (5.11)] Clinically Important Drug Interactions [see Warnings And Precautions (5.12)] Hyponatremia [see Warnings And Precautions (5.13)] Urinary Hesitation and Retention [see Warnings And Precautions (5.15)] Sexual Dysfunction [see Warnings and Precautions (5.16)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, a…
Frequently Asked Questions
What is Duloxetine D/R used for?
Duloxetine is an oral delayed-release capsule used to treat depression, anxiety disorders, pain conditions, and other health problems. It works by affecting certain chemicals in the brain and is available in a 30 mg strength as a prescription medication.
Is Duloxetine D/R a controlled substance?
Duloxetine D/R is not classified as a controlled substance by the DEA.
What is the generic name for Duloxetine D/R?
The generic name for Duloxetine D/R is Duloxetine D/R. There are no other listed brand versions of Duloxetine D/R.
What is the NDC code for Duloxetine D/R 30 mg/1?
The NDC (National Drug Code) for Duloxetine D/R 30 mg/1 is 72189-661, listed by Direct_Rx.
Other Duloxetine D/R Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)