Sertraline HCl 200 mg/1
Sertraline hydrochloride · CAPSULE · Biocon Pharma Inc.
Sertraline is an oral capsule medication used to treat depression, anxiety disorders, and related conditions by helping to balance certain chemicals in the brain. The 200 mg strength is taken by mouth as prescribed by your doctor.
Key Facts
- Brand Name
- Sertraline HCl
- Generic Name
- Sertraline hydrochloride
- NDC Code (Product)
70377-129- Manufacturer
- Biocon Pharma Inc.
- Strength
- 200 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218342
- Marketing Start
- 01/30/2026
Recall History
Pfizer Inc.
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Greenstone LLC
Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life
Aidapak Services, LLC
Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet,
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Pfizer Inc.
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Sertraline hydrochloride tablets are indicated for the treatment of the following [See CLINICAL STUDIES (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
Dosage & Administration
2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD The recommended initial dosage and maximum sertraline hydrochloride dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage. For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one week. Table 1: Recommended Daily Dosage of Sertraline Hydrochloride in Patients with MDD, OCD, PD, PTSD, and SAD Indication Starting Dose Therapeutic Range Adults MDD 50 mg 50 to 200 mg OCD 50 mg PD, PTSD, SAD 25 mg Pediatric Patients OCD (ages 6 to 12 years old) 25 mg 50 to 200 mg OCD (ages 13 to 17 years old) 50 mg 2.2 Dosage in Patients with PMDD The recommended starting sertraline hydrochloride dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only du…
Contraindications
Sertraline hydrochloride tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See WARNINGS AND PRECAUTIONS (5.2), DRUG INTERACTIONS (7.1)]. Taking pimozide [See DRUG INTERACTIONS (7.1)]. With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See ADVERSE REACTIONS (6.1, 6.2)].
Drug Interactions
7.1 Clinically Significant Drug Interactions Table 5 includes clinically significant drug interactions with sertraline hydrochloride [See CLINICAL PHARMACOLOGY (12.3)]. Table 5. Clinically-Significant Drug Interactions with Sertraline Hydrochloride Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including sertraline hydrochloride and MAOIs increases the risk of serotonin syndrome. Intervention: Sertraline hydrochloride is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [See DOSAGE AND ADMINISTRATION (2.5), CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2)]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide Clinical Impact: Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention: Concomitant use of pimozide and sertraline hydrochloride is contraindicated [See CONTRAINDICATIONS (4)]. Other Serotonergic Drugs Clinical Impact: The concomitant use of serotonergic drugs with sertraline hydrochloride increases the risk of serotonin …
Adverse Reactions
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See CONTRAINDICATIONS (4)] QTc prolongation and ventricular arrhythmias when taken with pimozide [See CONTRAINDICATIONS (4), CLINICAL PHARMACOLOGY (12.2)] Suicidal thoughts and behaviors [See WARNINGS AND PRECAUTIONS (5.1)] Serotonin syndrome [See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2), DRUG INTERACTIONS (7.1)] Increased risk of bleeding [See WARNINGS AND PRECAUTIONS (5.3)] Activation of mania/hypomania [See WARNINGS AND PRECAUTIONS (5.4)] Discontinuation syndrome [See WARNINGS AND PRECAUTIONS (5.5)] Seizures [See WARNINGS AND PRECAUTIONS (5.6)] Angle-closure glaucoma [See WARNINGS AND PRECAUTIONS (5.7)] Hyponatremia [See WARNINGS AND PRECAUTIONS (5.8)] Sexual Dysfunction [See WARNINGS AND PRECAUTIONS (5.11)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described…
Frequently Asked Questions
What is Sertraline HCl used for?
Sertraline is an oral capsule medication used to treat depression, anxiety disorders, and related conditions by helping to balance certain chemicals in the brain. The 200 mg strength is taken by mouth as prescribed by your doctor.
Is Sertraline HCl a controlled substance?
Sertraline HCl is not classified as a controlled substance by the DEA.
What is the generic name for Sertraline HCl?
The generic name for Sertraline HCl is Sertraline hydrochloride. There are 12 other brand versions of Sertraline hydrochloride.
What is the NDC code for Sertraline HCl 200 mg/1?
The NDC (National Drug Code) for Sertraline HCl 200 mg/1 is 70377-129, listed by Biocon Pharma Inc..
Other Sertraline Brands
See all →- Sertraline Hydrochloride50 mg/172162-2370
- Sertraline Hydrochloride50 mg/176420-781
- Sertraline Hydrochloride25 mg/10904-6924
- Sertraline Hydrochloride100 mg/10904-6926
- Sertraline Hydrochloride100 mg/143353-447
- Sertraline Hydrochloride50 mg/150090-6379
- Sertraline Hydrochloride50 mg/150090-6861
- SERTRALINE HYDROCHLORIDE100 mg/150090-7694
- Sertraline Hydrochloride25 mg/150090-7698
- Sertraline Hydrochloride50 mg/155154-4687
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)