Bupropion Hydrochloride 150 mg/1
Bupropion Hydrochloride · TABLET, EXTENDED RELEASE · American Health Packaging
Bupropion Hydrochloride is a tablet, extended release containing bupropion hydrochloride at 150 mg/1, taken oral. Manufactured by American Health Packaging.
Key Facts
- Brand Name
- Bupropion Hydrochloride
- Generic Name
- Bupropion Hydrochloride
- NDC Code (Product)
60687-782- Manufacturer
- American Health Packaging
- Strength
- 150 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090693
- Marketing Start
- 01/15/2024
Recall History
Jubilant Cadista Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Graviti Pharmaceuticals Private Limited
Failed Tablet/Capsule Specifications
Actavis Inc
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Amerisource Health Services LLC
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Actavis Inc
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Sun Pharmaceutical Industries, Inc.
Failed Dissolution Specifications
Sun Pharmaceutical Industries, Inc.
Failed Dissolution Specifications; 18 month stability time point
Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications; 6 month time point
Sun Pharma Global Fze
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Jubilant Cadista Pharmaceuticals, Inc.
Failed Dissolution Specifications; 9-monthstability timepoint
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) (1.1) prevention of seasonal affective disorder (SAD) ( 1.2) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1) ]. 1.2 Seasonal Affective Disorder (SAD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride e…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION General: Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Periodically reassess the dose and need for maintenance treatment. ( 2.2 ) Major Depressive Disorder Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily ( 2.2 ) After 4 days, may increase the dose to 300 mg once daily. ( 2.2 ) Seasonal Affective Disorder Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. ( 2.3 ) Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily. ( 2.3 ) After one week, may increase the dose to 300 mg once daily. ( 2.3 ) Continue treatment through the winter season. ( 2.3 ) Hepatic Impairment Moderate to severe hepatic impairment: 150 mg every other day ( 2.6 ) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.6 , 8.7 ) Renal Impairment Consider reducing the dose and/or frequency of dosing. ( 2.7 , 8.6 ) 2.1 General Instructions for Use To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3) ]. Bupropion hydrochloride extended-release tablets (XL) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydroch…
Contraindications
4 CONTRAINDICATIONS Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride extended-release tablets (XL) [see Warnings and Precautions (5.3) ]. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3) ]. The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (XL) is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (XL) within 14 days of discontinu…
Drug Interactions
7 DRUG INTERACTIONS CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical exposure, but should not exceed the maximum recommended dose. ( 7.1 ) Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide). Consider dose reduction when using with bupropion. ( 7.2 ) Drugs that lower seizure threshold: Dose bupropion hydrochloride extended-release tablets (XL) with caution. ( 5.3 , 7.3 ) Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion hydrochloride extended-release tablets (XL). ( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride extended-release tablets (XL). ( 7.6 ) Drug-laboratory test interactions: Bupropion hydrochloride extend…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings and Precautions (5.1) ] Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see Warnings and Precautions (5.2) ] Seizure [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Activation of mania or hypomania [see Warnings and Precautions (5.5) ] Psychosis and other neuropsychiatric events [see Warnings and Precautions (5.6) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.7) ] Hypersensitivity reactions [see Warnings and Precautions (5.8) ] Most common adverse reactions are (incidence ≥5%; ≥2× placebo rate): dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oryza Pharmaceuticals, Inc. at 1-866-637-4281, or FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted und…
Frequently Asked Questions
What is Bupropion Hydrochloride used for?
Bupropion Hydrochloride contains Bupropion Hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Bupropion Hydrochloride a controlled substance?
Bupropion Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Bupropion Hydrochloride?
The generic name for Bupropion Hydrochloride is Bupropion Hydrochloride. There are 9 other brand versions of Bupropion Hydrochloride.
What is the NDC code for Bupropion Hydrochloride 150 mg/1?
The NDC (National Drug Code) for Bupropion Hydrochloride 150 mg/1 is 60687-782, listed by American Health Packaging.
Other Bupropion Hydrochloride Dosages
Other Bupropion Brands
See all →- Bupropion Hydrochloride SR150 mg/172162-1529
- Bupropion Hydrochloride (XL)300 mg/177771-145
- BUPROPION HYDROCHLORIDE150 mg/180425-0461
- Bupropion Hydrochloride (XL)150 mg/183008-082
- Bupropion Hydrochloride (XL)300 mg/183301-0025
- Bupropion Hydrochloride XL300 mg/10904-7469
- bupropion hydrochloride150 mg/116571-862
- BUPROPION HYDROCHLORIDE100 mg/142806-410
- Bupropion Hydrochloride SR150 mg/143598-537
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)