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Sertraline 100 mg Tablet, Film Coated, 60-count — NDC 63187-0212-60 package photo

Sertraline 100 mg Tablet, Film Coated, 60-count

by Proficient Rx LP · 60 TABLET, FILM COATED in 1 BOTTLE (63187-212-60)
NDC 63187-0212-60
🏷️ FDA NDC (as labeled) 63187-212-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1097/unit — full pricing hub ↓
Also comes in: 30 tablets 63187-0212-30 90 tablets 63187-0212-90
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 63187-212-60
Product NDC 63187-212
11-digit billing NDC 63187021260
RxCUI 312938, 312940, 312941
UNII UTI8907Y6X
UPC 0363187212308, 0363187055301, 0363187478902
Application # ANDA077670
SPL Set ID 35dea1a2-ec26-4e52-8f09-ee4678e77946
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Cytochrome P450 2D6 Inhibitors; Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-02-06
Route ORAL
Dosage form TABLET, FILM COATED
Substance SERTRALINE HYDROCHLORIDE
GPI-14 58160070100320
GPI class Sertraline HCl
GCN Seq No 046229
GCN 16375
HICL code 006324
Ingredient (HICL) Sertraline Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2S
Therapeutic class — specific (HIC3) Selective Serotonin Reuptake Inhibitor (Ssris)
AHFS code 28:16.04.20
AHFS class Selective-Serotonin Reuptake Inhibitors
FDB label name SERTRALINE HCL 100 MG TABLET
FDB brand name Sertraline Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63187-212-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0212-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin Reuptake Inhibitor class.

Pharmacologic class Serotonin Reuptake Inhibitor
Drug family (ATC) Selective serotonin reuptake inhibitors
How it works Serotonin Uptake Inhibitors, Cytochrome P450 2D6 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderLUPIN LTD
FDA applicationANDA077670 (ANDA)
Labeler code63187
First marketedFeb 2007
Product typeHuman Prescription Drug
Portfolio1,723 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SERTRALINE HCL 100 MG TABLET Ingredient Sertraline Hcl
📖 What it is MedlinePlus · NLM

Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, (mood swings, irrita...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most people don't feel the full benefit right away — sertraline typically takes several weeks to build up to steady levels in your body. Some people notice small improvements in sl...
  • How long does it take for sertraline to start working?
  • You should be cautious. Sertraline affects the blood's ability to clot, and combining it with aspirin, ibuprofen, naproxen, or other anti-inflammatory pain relievers raises your ri...
  • Is it okay to take sertraline with ibuprofen or aspirin?
📖 Read our full Sertraline guide →
1
Nutrient depletion considerations

Sertraline may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Sertraline nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Green / Blue / Yellow
ShapeCapsule
ImprintL;U;D03
Size13 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1097 $6.58 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sertraline Hydrochloride 100 mg 16729-0217-15 Accord 90 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 00904-6926-61 Major 1 tablet $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 16714-0613-01 NorthStar 30 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 31722-0147-05 Camber 500 tablets $0.050 — Availability likely —
Sertraline 100 mg 50268-0770-15 AvPAK 1 tablet $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 50268-0825-15 AvPAK 1 tablet $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 60687-0253-01 American 100 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 65862-0013-01 Aurobindo 100 tablets $0.050 — Availability likely —
Sertraline Hydrochloride 100 mg 68180-0992-01 Lupin 30 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 68645-0523-54 Legacy 30 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 69097-0835-02 Cipla 30 tablets $0.050 AB Availability likely —
Sertraline hydrochloride 100 mg 70010-0205-03 Granules 30 tablets $0.050 AB Availability likely —
Sertraline 100 mg 76282-0214-01 Exelan 100 tablets $0.050 AB Discontinued —
Sertraline Hydrochloride 100 mg 82009-0050-05 Quallent 500 tablets $0.050 AB Availability likely —
Zoloft 100 mg 00049-4910-30 ROERIG 30 tablets $14.947 AB Discontinued —
Zoloft 100 mg 58151-0576-88 Viatris 1 tablet $14.950 AB Availability likely —
Sertraline Hydrochloride 100 mg 00615-8604-05 NCS 15 tablets — AB FDA listed —
Sertraline 100 mg 23155-0759-03 Heritage 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43063-0754-30 PD-Rx 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43353-0447-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43602-0981-15 Ascent 30 tablets — — FDA listed —
Sertraline 100 mg 50090-0991-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-2080-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-3203-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-6917-00 A-S 90 tablets — AB FDA listed —
Sertraline 100 mg 50090-7295-00 A-S 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-7693-00 A-S 30 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 50090-7694-00 A-S 90 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 50090-7700-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-7701-00 A-S 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50228-0469-05 ScieGen 500 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 51655-0173-26 Northwind 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 55154-3570-00 Cardinal 1 tablet — AB FDA listed —
Sertraline Hydrochloride 100 mg 55154-4692-00 Cardinal 10 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 55700-0362-30 Quality 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 60760-0091-90 St. 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 60760-0738-90 St. 90 tablets — AB FDA listed —
Sertraline 100 mgthis 63187-0212-60 Proficient 60 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 63187-0795-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 67046-0554-03 Coupler 30 tablets — AB FDA listed —
Sertraline hydrochloride 100 mg 67046-1682-03 Coupler 30 tablets — AB FDA listed —
Sertraline 100 mg 68071-3534-03 NuCare 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68071-4658-03 NuCare 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68071-4973-06 NuCare 60 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68180-0353-01 Lupin 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68788-6835-01 Preferred 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68788-8210-03 Preferred 30 tablets — AB FDA listed —
Sertraline 100 mg 70518-1040-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 70518-2448-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 70518-4590-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71205-0047-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71205-0455-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71335-0210-01 Bryant 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71335-0510-01 Bryant 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71335-0896-01 Bryant 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71335-3110-01 Bryant 30 tablets — AB FDA listed —
Sertraline 100 mg 71335-3115-01 Bryant 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71610-0433-15 Aphena 15 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71610-0435-45 Aphena 45 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71610-0651-15 Aphena 15 tablets — AB FDA listed —
Sertraline 100 mg 71610-0769-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71610-0886-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72162-2407-03 Bryant 30 tablets — AB FDA listed —
Sertraline 100 mg 72162-2411-00 Bryant 1000 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72189-0122-30 DIRECT 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0088-60 PD-Rx 60 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0092-30 PD-Rx 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0273-01 PD-Rx 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72865-0207-05 XLCare 500 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 76420-0786-01 Asclemed 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 80425-0310-01 Advanced 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 84386-0099-59 Aurobindo 5000 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2007
On the market since
Feb 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sertraline — the ingredient across all brands.

Top reported reactions

Nausea13,865
Fatigue12,822
Headache11,106
Anxiety10,369
Diarrhoea10,339
Dizziness9,602
Depression9,506

Age at onset

Neonate667
Infant107
Child310
Adolescent1,168
Adult16,853
Elderly8,818

Reporter sex

218,320 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization68,335
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16,834 6,832
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63187-0212-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-212-30) 2015-05-01 Active
63187-0212-60 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE (63187-212-60) 2015-05-01 Active
63187-0212-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-212-90) 2015-05-01 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0212-60?
NDC 63187-0212-60 is a 60-count package — 60 tablet, film coated in 1 bottle.
What is the difference between NDC 63187-0212-60 and NDC 63187-0212-30?
Both are Sertraline 100 mg Tablet, Film Coated — the drug itself is identical. NDC 63187-0212-60 is the 60-count package, while NDC 63187-0212-30 is the 30 tablets package.
What NDC number is used to bill for this package of Sertraline 100 mg Tablet, Film Coated?
Bill NDC 63187-0212-60 — the 11-digit billing format is 63187021260. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63187-212-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63187-0212-60, written without dashes as 63187021260. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63187-0212-60, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0212) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (63187-0212-30), 90 tablets (63187-0212-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 196 words ▾

Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of sertraline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.

Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Sertraline is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See WARNINGS : Clinical Worsening and Suicide Risk , PRECAUTIONS : Information for Patients , and PRECAUTIONS : Pediatric Use )

🎯 Indications and Usage ~3 min read ▾

INDICATIONS AND USAGE Major Depressive Disorder Sertraline tablets USP are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline tablets USP in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The antidepressant action of sertraline tablets USP in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline tablets USP in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline tablets USP for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY ).

Obsessive-Compulsive Disorder Sertraline tablets USP are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline tablets USP were established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY ).

Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of sertraline tablets USP in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline tablets USP and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY ).

Nevertheless, the physician who elects to use sertraline tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Panic Disorder Sertraline tablets USP are indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of sertraline tablets USP were established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY ). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) fee…

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Initial Treatment Dosage for Adults Major Depressive Disorder and Obsessive-Compulsive Disorder: Sertraline treatment should be administered at a dose of 50 mg once daily. Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder: Sertraline treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.

While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50 to 200 mg/day in the clinical trials demonstrating the effectiveness of sertraline for the treatment of these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day.

Given the 24 hour elimination half-life of sertraline, dose changes should not occur at intervals of less than 1 week. Premenstrual Dysphoric Disorder: Sertraline treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment. While a relationship between dose and effect has not been established for PMDD, patients were dosed in the range of 50 to 150 mg/day with dose increases at the onset of each new menstrual cycle (see Clinical Trials under CLINICAL PHARMACOLOGY ).

Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period. Sertraline should be administered once daily, either in the morning or evening.

Dosage for Pediatric Population (Children and Adolescents) Obsessive-Compulsive Disorder: Sertraline treatment should be initiated with a dose of 25 mg once daily in children (ages 6 to 12) and at a dose of 50 mg once daily in adolescents (ages 13 to 17). While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25 to 200 mg/day in the clinical trials demonstrating the effectiveness of sertraline for pediatric patients (6 to 17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day.

For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of sertraline, dose changes should not occur at intervals of less than 1 week. Sertraline should be administered once daily, either in the morning or evening.

Maintenance/Continuation/Extended Treatment Major Depressive Disorder It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of sertraline has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50 to 200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY ).

It is not known whether the dose of sertraline needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment. Posttraumatic Stress Disorder It is generally agreed that PTSD requires several months or longer of sustained pharmacological therapy beyond response to initial treatment.

Systematic evaluation…

⛔ Contraindications 129 words ▾

CONTRAINDICATIONS All Dosage Forms of Sertraline The use of MAOIs intended to treat psychiatric disorders with sertraline or within 14 days of stopping treatment with sertraline is contraindicated because of an increased risk of serotonin syndrome. The use of sertraline within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting sertraline in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ).

Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS ). Sertraline tablets are contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in sertraline tablets.

⚠️ Warnings ~3 min read ▾

WARNINGS Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders.

Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients.

There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications.

These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1. Table 1 Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated Increases Compared to Placebo <18 14 additional cases 18 to 24 5 additional cases Decreases Compared to Placebo 25 to 64 1 fewer case ≥65 6 fewer cases No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changin…

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS During its premarketing assessment, multiple doses of sertraline were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder, OCD, panic disorder, PTSD, PMDD and social anxiety disorder.

Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories. In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events.

The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of sertraline who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving sertraline. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it.

The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.

Incidence in Placebo-Controlled Trials Table 2 enumerates the most common treatment- emergent adverse events associated with the use of sertraline (incidence of at least 5% for sertraline and at least twice that for placebo within at least one of the indications) for the treatment of adult patients with major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder in placebo-controlled clinical trials. Most patients in major depressive disorder/other*, OCD, panic disorder, PTSD and social anxiety disorder studies received doses of 50 to 200 mg/day.

Patients in the PMDD study with daily dosing throughout the menstrual cycle received doses of 50 to 150 mg/day, and in the PMDD study with dosing during the luteal phase of the menstrual cycle received doses of 50 to 100 mg/day. Table 3 enumerates treatment-emergent adverse events that occurred in 2% or more of adult patients treated with sertraline and with incidence greater than placebo who participated in controlled clinical trials comparing sertraline with placebo in the treatment of major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder.

Table 3 provides combined data for the pool of studies that are provided separately by indication in Table 2. TABLE 1 MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event Major Depressive Disorder/Other Major depressive disorder and other premarketing controlled trials. OCD Panic Disorder PTSD Body System/Adverse Event Sertraline (N=861) Placebo (N=853) Sertraline (N=533) Placebo (N=373) Sertraline (N=430) Placebo (N=275) Sertraline (N=374) Placebo (N=376) Autonomic Nervous System Disorders Ejaculation Fail…

🔄 Drug Interactions ~3 min read ▾

Drug Interactions Potential Effects of Coadministration of Drugs Highly Bound to Plasma Proteins Because sertraline is tightly bound to plasma protein, the administration of sertraline hydrochloride to a patient taking another drug which is tightly bound to protein (e.g., warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely, adverse effects may result from displacement of protein bound sertraline by other tightly bound drugs. In a study comparing prothrombin time AUC (0 to 120 hr) following dosing with warfarin (0.75 mg/kg) before and after 21 days of dosing with either sertraline (50 to 200 mg/day) or placebo, there was a mean increase in prothrombin time of 8% relative to baseline for sertraline compared to a 1% decrease for placebo (p<0.02).

The normalization of prothrombin time for the sertraline group was delayed compared to the placebo group. The clinical significance of this change is unknown. Accordingly, prothrombin time should be carefully monitored when sertraline therapy is initiated or stopped.

Cimetidine In a study assessing disposition of sertraline (100 mg) on the second of 8 days of cimetidine administration (800 mg daily), there were significant increases in sertraline mean AUC (50%), C max (24%) and half-life (26%) compared to the placebo group. The clinical significance of these changes is unknown. CNS Active Drugs In a study comparing the disposition of intravenously administered diazepam before and after 21 days of dosing with either sertraline (50 to 200 mg/day escalating dose) or placebo, there was a 32% decrease relative to baseline in diazepam clearance for the sertraline group compared to a 19% decrease relative to baseline for the placebo group (p<0.03).

There was a 23% increase in T max for desmethyldiazepam in the sertraline group compared to a 20% decrease in the placebo group (p<0.03). The clinical significance of these changes is unknown. In a placebo-controlled trial in normal volunteers, the administration of two doses of sertraline did not significantly alter steady-state lithium levels or the renal clearance of lithium.

Nonetheless, at this time, it is recommended that plasma lithium levels be monitored following initiation of sertraline therapy with appropriate adjustments to the lithium dose. In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline (q.d.) co- administration to steady state was associated with a mean increase in pimozide AUC and C max of about 40%, but was not associated with any changes in EKG. Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline, the effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known.

While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of sertraline and pimozide should be contraindicated (see CONTRAINDICATIONS ). Results of a placebo-controlled trial in normal volunteers suggest that chronic administration of sertraline 200 mg/day does not produce clinically important inhibition of phenytoin metabolism. Nonetheless, at this time, it is recommended that plasma phenytoin concentrations be monitored following initiation of sertraline therapy with appropriate adjustments to the phenytoin dose, particularly in patients with multiple underlying medical conditions and/or those receiving multiple concomitant medications.

The effect of sertraline on valproate levels has not been evaluated in clinical trials. In the absence of such data, it is recommended that plasma valproate levels be monitored following initiation of sertraline therapy with appropriate adjustments to the valproate dose. The risk of using sertraline in combination with other CNS active drugs has not been systematically evaluated.

Consequently, caution is advised if the concomitant admi…

🧒 Pediatric Use ~3 min read ▾

Pediatric Use The efficacy of sertraline for the treatment of obsessive-compulsive disorder was demonstrated in a 12-week, multicenter, placebo-controlled study with 187 outpatients ages 6 to 17 (see Clinical Trials under CLINICAL PHARMACOLOGY ). Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established (see Error! Hyperlink reference not valid. and WARNINGS - Clinical Worsening and Suicide Risk ).

Two placebo controlled trials (n=373) in pediatric patients with MDD have been conducted with sertraline, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of sertraline in a child or adolescent must balance the potential risks with the clinical need. The safety of sertraline use in children and adolescents with OCD, ages 6 to 18, was evaluated in a 12-week, multicenter, placebo-controlled study with 187 outpatients, ages 6 to 17, and in a flexible dose, 52 week open extension study of 137 patients, ages 6 to 18, who had completed the initial 12-week, double-blind, placebo-controlled study. sertraline was administered at doses of either 25 mg/day (children, ages 6 to 12) or 50 mg/day (adolescents, ages 13 to 18) and then titrated in weekly 25 mg/day or 50 mg/day increments, respectively, to a maximum dose of 200 mg/day based upon clinical response.

The mean dose for completers was 157 mg/day. In the acute 12 week pediatric study and in the 52 week study, sertraline had an adverse event profile generally similar to that observed in adults. Sertraline pharmacokinetics were evaluated in 61 pediatric patients between 6 and 17 years of age with major depressive disorder or OCD and revealed similar drug exposures to those of adults when plasma concentration was adjusted for weight (see Pharmacokinetics under CLINICAL PHARMACOLOGY ).

Approximately 600 patients with major depressive disorder or OCD between 6 and 17 years of age have received sertraline in clinical trials, both controlled and uncontrolled. The adverse event profile observed in these patients was generally similar to that observed in adult studies with sertraline (see ADVERSE REACTIONS ). As with other SSRIs, decreased appetite and weight loss have been observed in association with the use of sertraline.

In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50 to 200 mg) outpatient trials for major depressive disorder (n=373), there was a difference in weight change between sertraline and placebo of roughly 1 kilogram, for both children (ages 6 to 11) and adolescents (ages 12 to 17), in both cases representing a slight weight loss for sertraline compared to a slight gain for placebo. At baseline the mean weight for children was 39.0 kg for sertraline and 38.5 kg for placebo. At baseline the mean weight for adolescents was 61.4 kg for sertraline and 62.5 kg for placebo.

There was a bigger difference between sertraline and placebo in the proportion of outliers for clinically important weight loss in children than in adolescents. For children, about 7% had a weight loss > 7% of body weight compared to none of the placebo patients; for adolescents, about 2% had a weight loss > 7% of body weight compared to about 1% of the placebo patients. A subset of these patients who completed the randomized controlled trials (sertraline n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study.

A mean weight loss of approximately 0.5 kg was seen during the first eight weeks of treatment for subjects with first exposure to sertraline during the open-label extension study, similar to mean weight loss observed among sertraline treated subjects during the first eight weeks of the randomized controlled trials. The subjects continuing in the open label study began gaining weight compared to baseline by week 12 of sertraline treatment. Those subjects who completed 34 weeks of sertraline treatment (10 weeks in a pl…

🧓 Geriatric Use ~1 min read ▾

Geriatric Use U.S. geriatric clinical studies of sertraline in major depressive disorder included 663 sertraline-treated subjects ≥ 65 years of age, of those, 180 were ≥ 75 years of age. No overall differences in the pattern of adverse reactions were observed in the geriatric clinical trial subjects relative to those reported in younger subjects (see ADVERSE REACTIONS ), and other reported experience has not identified differences in safety patterns between the elderly and younger subjects. As with all medications, greater sensitivity of some older individuals cannot be ruled out.

There were 947 subjects in placebo-controlled geriatric clinical studies of sertraline in major depressive disorder. No overall differences in the pattern of efficacy were observed in the geriatric clinical trial subjects relative to those reported in younger subjects. Other Adverse Events in Geriatric Patients.

In 354 geriatric subjects treated with sertraline in placebo-controlled trials, the overall profile of adverse events was generally similar to that shown in Tables 2 and 3. Urinary tract infection was the only adverse event not appearing in Tables 2 and 3 and reported at an incidence of at least 2% and at a rate greater than placebo in placebo-controlled trials. SSRIS and SNRIs, including sertraline, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see PRECAUTIONS , Hyponatremia ).

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Human Experience Of 1,027 cases of overdose involving sertraline hydrochloride worldwide, alone or with other drugs, there were 72 deaths (circa 1999). Among 634 overdoses in which sertraline hydrochloride was the only drug ingested, 8 resulted in fatal outcome, 75 completely recovered, and 27 patients experienced sequelae after overdosage to include alopecia, decreased libido, diarrhea, ejaculation disorder, fatigue, insomnia, somnolence and serotonin syndrome. The remaining 524 cases had an unknown outcome.

The most common signs and symptoms associated with non-fatal sertraline hydrochloride overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. The largest known ingestion was 13.5 grams in a patient who took sertraline hydrochloride alone and subsequently recovered. However, another patient who took 2.5 grams of sertraline hydrochloride alone experienced a fatal outcome.

Other important adverse events reported with sertraline hydrochloride overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, serotonin syndrome, stupor and syncope. Overdose Management Treatment should consist of those general measures employed in the management of overdosage with any antidepressant. Ensure an adequate airway, oxygenation and ventilation.

Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended.

Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Due to large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.

No specific antidotes for sertraline are known. In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of any overdose.

Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference ® (PDR ® ).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics The mechanism of action of sertraline is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT). Studies at clinically relevant doses in man have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake.

In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha 1 , alpha 2 , beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT 1A , 5HT 1B , 5HT 2 ), or benzodiazepine receptors; antagonism of such receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. The chronic administration of sertraline was found in animals to down regulate brain norepinephrine receptors, as has been observed with other drugs effective in the treatment of major depressive disorder.

Sertraline does not inhibit monoamine oxidase. Pharmacokinetics Systemic Bioavailability In man, following oral once-daily dosing over the range of 50 to 200 mg for 14 days, mean peak plasma concentrations (C max ) of sertraline occurred between 4.5 to 8.4 hours post-dosing. The average terminal elimination half-life of plasma sertraline is about 26 hours.

Based on this pharmacokinetic parameter, steady-state sertraline plasma levels should be achieved after approximately one week of once-daily dosing. Linear dose-proportional pharmacokinetics were demonstrated in a single dose study in which the C max and area under the plasma concentration time curve (AUC) of sertraline were proportional to dose over a range of 50 to 200 mg. Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation, compared to a single dose, of sertraline with repeated dosing over a 50 to 200 mg dose range.

The single dose bioavailability of sertraline tablets is approximately equal to an equivalent dose of solution. In a relative bioavailability study comparing the pharmacokinetics of 100 mg sertraline as the oral solution to a 100 mg sertraline tablet in 16 healthy adults, the solution to tablet ratio of geometric mean AUC and C max values were 114.8% and 120.6%, respectively. 90% confidence intervals (CI) were within the range of 80 to 125% with the exception of the upper 90% CI limit for C max which was 126.5%.

The effects of food on the bioavailability of the sertraline tablet was studied in subjects administered a single dose with and without food. For the tablet, AUC was slightly increased when drug was administered with food but the C max was 25% greater, while the time to reach peak plasma concentration (T max ) decreased from 8 hours post-dosing to 5.5 hours. Metabolism Sertraline undergoes extensive first pass metabolism.

The principal initial pathway of metabolism for sertraline is N-demethylation. N-desmethylsertraline has a plasma terminal elimination half-life of 62 to 104 hours. Both in vitro biochemical and in vivo pharmacological testing have shown N-desmethylsertraline to be substantially less active than sertraline.

Both sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation, and glucuronide conjugation. In a study of radiolabeled sertraline involving two healthy male subjects, sertraline accounted for less than 5% of the plasma radioactivity. About 40 to 45% of the administered radioactivity was recovered in urine in 9 days.

Unchanged sertraline was not detectable in the urine. For the same period, about 40 to 45% of the administered radioactivity was accounted for in feces, including 12 to 14% unchanged sertraline. Desmethylsertraline exhibits time-related, dose dependent increases in AUC (0-24 hour), C max and C min , with about a 5 to 9 fold increase in these…

📦 How Supplied / Storage and Handling 215 words ▾

HOW SUPPLIED Sertraline capsule-shaped, film-coated tablets, containing sertraline hydrochloride equivalent to 50 mg of sertraline, are packaged in bottles as well as unit dose blisters. Sertraline Tablets USP, 25 mg: green colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' & 'U' on either side of the breakline on one side and 'D01' on the other side. NDC 63187-478-30 Bottles of 30 NDC 63187-478-60 Bottles of 60 NDC 63187-478-90 Bottles of 90 Sertraline Tablets USP, 50 mg: blue colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' & 'U' on either side of the breakline on one side and 'D02' on the other side.

NDC 63187-055-30 Bottles of 30 NDC 63187-055-60 Bottles of 60 NDC 63187-055-90 Bottles of 90 Sertraline Hydrochloride Tablets USP, 100 mg: yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side. NDC 63187-212-30 Bottles of 30 NDC 63187-212-60 Bottles of 60 NDC 63187-212-90 Bottles of 90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA Revised: March 15, 2014 ID#: 237062 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

📋 Description 158 words ▾

DESCRIPTION Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride.

The empirical formula C 17 H 17 NCl 2 •HCl is represented by the following structural formula: Sertraline hydrochloride is a white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride is supplied for oral administration as film-coated tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: D & C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD & C Blue #1 (in 25 mg tablet), FD & C Blue #2 (in 50 mg tablet), FD & C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.

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💬 Information for Patients 141 words ▾

Information for Patients Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with sertraline and should counsel them in its appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions: is available for sertraline. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.

Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking sertraline.

💬 Medication Guide ~3 min read ▾

Medication Guide SERTRALINE TABLETS USP (ser′ tra leen) 50 mg Rx only Read the Medication Guide that comes with Sertraline Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about sertraline tablets? Sertraline tablets and other antidepressant medicines may cause serious side effects, including: 1.

Suicidal thoughts or actions: • Sertraline and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when sertraline tablets are started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual changes in behavior or mood Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency.

Sertraline tablets may be associated with these serious side effects: 2. Serotonin Syndrome This condition can be life-threatening and may include: • agitation, hallucinations, coma or other changes in mental status • coordination problems or muscle twitching (overactive reflexes) • racing heartbeat, high or low blood pressure • sweating or fever • nausea, vomiting, or diarrhea • muscle rigidity 3. Severe allergic reactions: • trouble breathing • swelling of the face, tongue, eyes or mouth • rash, itchy welts (hives) or blisters, alone or with fever or joint pain 4.

Abnormal bleeding: Sertraline and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ® ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin. 5. Seizures or convulsions 6.

Manic episodes: • greatly increased energy • severe trouble sleeping • racing thoughts • reckless behavior • unusually grand ideas • excessive happiness or irritability • talking more or faster than usual 7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this.

Symptoms may include: • headache • weakness or feeling unsteady • confusion, problems concentrating or thinking or memory problems Do not stop sertraline tablets without first talking to your healthcare provider. Stopping sertraline tablets too quickly may cause serious symptoms including: • anxiety, irritability, high or low mood, feeling restless or changes in sleep habits • headache, sweating, nausea, dizziness • electric shock-like sensations, shaking, confusion What are sertraline tablets? Sertraline tablets are prescription medicines used to treat depression.

It is important to talk with your healthcare provider about the risks of treating depression and al…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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