Quick answers
- What is Sertraline hydrochloride used for?
- The FDA-approved label (Zoloft, Viatris Specialty LLC, August 8, 2023) says: “ZOLOFT is indicated for the treatment of the following […]: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sertraline hydrochloride have a boxed warning?
- Yes. The FDA label for Zoloft has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sertraline hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sertraline hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 5, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Sertraline hydrochloride?
- 48 companies list prescription products of Sertraline hydrochloride in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Remedyrepack Inc..
What Sertraline hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZOLOFT is indicated for the treatment of the following […]: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of …
— FDA label: Zoloft, Viatris Specialty LLC, effective August 8, 2023. Read the full label on DailyMed →
The FDA has 152 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
. Read it on the full label →
152 of 152 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Capsule · Solution, concentrate · Solution |
|---|---|
| Route | Oral |
| Prescription products | 227 in the FDA NDC Directory |
| Brand names | Zoloft |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| sertraline hydrochloride 100 mg tablet | Generic | $0.0511 per tablet |
| sertraline hydrochloride 100 mg tablet, film coated | Generic | $0.0511 per tablet |
| sertraline hydrochloride 100 mg tablet, film coated | Brand: Zoloft | $14.94 per tablet |
| sertraline hydrochloride 150 mg capsule | Generic | $1.15 per capsule |
| sertraline hydrochloride 20 mg/mL solution | Generic | $0.3932 per mL |
| sertraline hydrochloride 20 mg/mL solution, concentrate | Generic | $0.3932 per mL |
| sertraline hydrochloride 200 mg capsule | Generic | $1.47 per capsule |
| sertraline hydrochloride 25 mg tablet | Generic | $0.0284 per tablet |
| sertraline hydrochloride 25 mg tablet, film coated | Generic | $0.0284 per tablet |
| sertraline hydrochloride 25 mg tablet, film coated | Brand: Zoloft | $15.17 per tablet |
| sertraline hydrochloride 50 mg tablet | Generic | $0.0348 per tablet |
| sertraline hydrochloride 50 mg tablet, film coated | Generic | $0.0348 per tablet |
| sertraline hydrochloride 50 mg tablet, film coated | Brand: Zoloft | $14.92 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions28 products
- Bryant Ranch Prepack19 products
- Remedyrepack Inc.15 products
- Proficient Rx LP12 products
- Preferred Pharmaceuticals Inc.9 products
- PD-Rx Pharmaceuticals, Inc.8 products
- NuCare Pharmaceuticals, Inc.8 products
- Aurobindo Pharma Limited7 products
- Aphena Pharma Solutions - Tennessee, LLC6 products
- Coupler LLC6 products
- AvPAK6 products
- Lupin Pharmaceuticals, Inc.6 products
- Cipla USA Inc.5 products
- St. Mary's Medical Park Pharmacy5 products
- NorthStar Rx LLC4 products
- Northwind Health Company, LLC4 products
- Cardinal Health 107, LLC4 products
- Viatris Specialty LLC4 products
- Major Pharmaceuticals3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- Ascent Pharmaceuticals Inc3 products
- ScieGen Pharmaceuticals, Inc.3 products
- Granules Pharmaceuticals Inc.3 products
- Asclemed USA, Inc.3 products
- XLCare Pharmaceuticals, Inc.3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Unit Dose Solutions, Inc.3 products
- Accord Healthcare Inc.3 products
- Legacy Pharmaceutical Packaging, LLC3 products
- Camber Pharmaceuticals, Inc.3 products
- American Health Packaging3 products
- Umedica Laboratories USA Inc.2 products
- Amneal Pharmaceuticals NY LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- QPharma, Inc.2 products
- Alvogen Inc.2 products
- Biocon Pharma Inc.2 products
- ANI Pharmaceuticals, Inc.2 products
- Direct_Rx2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- TruPharma, LLC2 products
- Quality Care Products, LLC2 products
- Zydus Lifesciences Limited2 products
- Dr. Reddy's Laboratories Inc.2 products
- Quallent Pharmaceuticals Health LLC2 products
- Almatica Pharma LLC2 products
- Rising Pharma Holdings, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019839 ZOLOFT | Viatris | December 30, 1991 | 68, latest August 18, 2023 2023: Labeling · 2023: Labeling · 2021: Labeling |
| NDA020990 ZOLOFT | Viatris | December 7, 1999 | 42, latest August 18, 2023 2023: Labeling · 2023: Labeling · 2021: Labeling |
| NDA215133 SERTRALINE HYDROCHLORIDE | Almatica | October 4, 2021 | 2, latest October 6, 2026 2026: Labeling · 2023: Labeling |
Generic approvals (17)
- ANDA076934Strides Pharma · June 30, 2006
- ANDA076465Heritage · August 11, 2006
- ANDA077206Aurobindo Pharma · February 6, 2007
- ANDA077397Invagen Pharms · February 6, 2007
- ANDA077670Lupin · February 6, 2007
- ANDA077713Tp Anda Holdings · February 6, 2007
- ANDA076442Sciegen Pharms · April 30, 2007
- ANDA078403Granules · January 8, 2008
- ANDA078861Aurobindo Pharma · October 31, 2008
- ANDA202825Accord Hlthcare · November 7, 2014
- ANDA214790Ascent Pharms Inc · May 3, 2021
- ANDA218853Zenara · July 16, 2025
- ANDA218342Umedica · January 20, 2026
- ANDA218712Appco · January 20, 2026
- ANDA219714Novitium Pharma · January 20, 2026
- ANDA219655Amneal · January 28, 2026
- ANDA220275Zydus Lifesciences · January 29, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 5, 2025 · Class II · Ongoing · D-0227-2026
Defective container - seal not adhering to bottles
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09. — Lupin Pharmaceuticals Inc.
-
December 11, 2023 · Class II · Ongoing · D-0205-2024
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, — Legacy Pharmaceutical Packaging LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zoloft, Viatris Specialty LLC, effective August 8, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →