What this pack is
ELAVIL is the brand name in this record; amitriptyline hydrochloride immediate-release tablets is the generic name. Read both together with the dosage form (multiple forms (oral tablets and injectable product)).
PACK CHECK · MARKET FIRST
ELAVILGeneric nameamitriptyline hydrochloride immediate-release tablets
How this medicine works
Amitriptyline is a tricyclic antidepressant. Current-label pharmacology can help explain why its monoamine-reuptake and other receptor effects come with sedation, anticholinergic and cardiovascular cues. Mechanism explains a pharmacologic relationship only; it cannot decide individual suitability, tablet count, timing or co-use with another psychiatric or pain medicine.
Read source: United States ↗reviewed 2026-09-13More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- ELAVIL
- Source-scoped market brand names
- ELAVIL · United StatesHistorical regulator record ↗NDA 012703: historical 10/25/50/75/100/150 mg single-ingredient oral tablets are RLD entries and currently DISCN; regulatory history is not live-supply evidence.
- AMITRIPTYLINE HYDROCHLORIDE · United StatesSource-scoped evidence ↗The current publicly readable source is a Zydus generic label; it is not rewritten as an original ELAVIL pack.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- amitriptyline hydrochloride immediate-release tablets
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PACKAGE-VISUAL STATUS
ELAVIL image withheld: a historical originator and a current generic label are not one package
This review retains the historical FDA identity for ELAVIL oral tablets and a current public generic amitriptyline label, but no exact public image was retained that matches historical ELAVIL, one strength, one pack and a primary source one-to-one. To avoid presenting generic, injectable, other-market, historical-version or source-uncertain imagery as the originator appearance, this page shows no package image.
LABEL READING · NOT A PRESCRIPTION
Amitriptyline enlarged-label reading: first separate historical brand, mg per tablet, sedation/falls and related medicines
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Historical ELAVIL 10/25/50/75/100/150 mg figures are amitriptyline hydrochloride strengths per tablet. They are not an individual's tablet count and cannot be self-interchanged by numbers with injection, combinations, another tricyclic antidepressant, an SSRI/SNRI, sedatives or alcohol. The current public leaflet is generic and must be checked item by item against the pack in hand for ingredient, form, strength, market and document version.
- The current label carries a boxed warning about suicidal thoughts and behaviours in children, adolescents and young adults. With self-harm/suicide thoughts, marked behaviour change or an urgent safety concern, use local emergency or crisis support immediately; do not wait for a website assessment or self-stop, increase or switch.
- Drowsiness, dizziness, unsteadiness on standing, blurred vision, dry mouth, constipation or urinary difficulty should be reviewed against the exact pack and complete medicine list. Older adults, people at dementia or fall risk, those with glaucoma or urinary problems, and people using alcohol, opioids, benzodiazepines, antihistamines or another sedative especially need professional review.
- An MAOI, another serotonergic medicine, tramadol, linezolid, intravenous methylene blue, some rhythm medicines, or a product affecting the central nervous system or cardiac rhythm on the same list requires professional interaction and rhythm-risk review. Do not self-combine, separate, alternate or substitute leftovers.
- Fainting, marked palpitations, seizure, severe altered awareness, breathing difficulty, face/lip/tongue/throat swelling or inability to remain safe requires local emergency services immediately with every medicine pack; the site does not decide interruption, make-up use or an increase.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-13
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. generic amitriptyline hydrochloride film-coated tablet label (Zydus Lifesciences; updated 4 Oct 2025) ↗reviewed 2026-09-13
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Orange Book data files: historical U.S. ELAVIL (amitriptyline hydrochloride) 10/25/50/75/100/150 mg oral-tablet RLD entries under NDA 012703; all DISCN and not withdrawn for safety or effectiveness ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about ELAVIL (amitriptyline hydrochloride immediate-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
ELAVIL is the brand in this record and amitriptyline hydrochloride immediate-release tablets is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. generic amitriptyline hydrochloride film-coated tablet label (Zydus Lifesciences; updated 4 Oct 2025) ↗reviewed 2026-09-13
- FDA Orange Book data files: historical U.S. ELAVIL (amitriptyline hydrochloride) 10/25/50/75/100/150 mg oral-tablet RLD entries under NDA 012703; all DISCN and not withdrawn for safety or effectiveness ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How amitriptyline works: tricyclic monoamine-reuptake and anticholinergic effects do not make medicines self-interchangeable
- ELAVIL, NORPRAMIN, SINEQUAN, PAMELOR, TRAZODONE, CELEXA, LEXAPRO and ZOLOFT are not the same medicine. A shared relationship to mood, sleep or pain concerns does not establish milligram conversion, alternation or combination.
- Everyday descriptions such as “helps sleep” or “helps pain” do not turn a product into a freely addable sleep or pain medicine. Actual indication, contraindications, age, cardiac status, other central-nervous-system medicines and the local label must be checked item by item.
- Genetic screening is not the site's default answer for choosing amitriptyline. If the responsible team believes pharmacogenetics, ECG, electrolytes, kidney/liver function or another test may change an individual decision, that team should explain it using the exact medicine and complete clinical information.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- FDA Orange Book data files: historical U.S. ELAVIL (amitriptyline hydrochloride) 10/25/50/75/100/150 mg oral-tablet RLD entries under NDA 012703; all DISCN and not withdrawn for safety or effectiveness ↗reviewed 2026-08-29
- DailyMed (NLM): current U.S. generic amitriptyline hydrochloride film-coated tablet label (Zydus Lifesciences; updated 4 Oct 2025) ↗reviewed 2026-09-13
SOURCE-TRACEABLE ARCHIVE
ELAVILamitriptyline hydrochloride immediate-release tablets
This page links to public primary-source material for ELAVIL. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Historical oral-tablet approval is recorded only as “prior to 1982”
FDA Orange Book oral-tablet entries under NDA 012703 use the field “Approved Prior to Jan 1, 1982.” The site does not invent a specific approval date from that field.
FDA Orange Book data files: historical U.S. ELAVIL (amitriptyline hydrochloride) 10/25/50/75/100/150 mg oral-tablet RLD entries under NDA 012703; all DISCN and not withdrawn for safety or effectiveness ↗Current public generic label updated
The Zydus amitriptyline hydrochloride film-coated-tablet label supports reading current class and safety boundaries; it does not replace historical ELAVIL pack evidence.
DailyMed (NLM): current U.S. generic amitriptyline hydrochloride film-coated tablet label (Zydus Lifesciences; updated 4 Oct 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Historical RLD; currently DISCNFDA historical RLD entries for ELAVIL 10/25/50/75/100/150 mg oral tablets are all DISCN and not withdrawn for safety or effectiveness; this is not live-supply evidence.
United States
Current public generic labelThe public leaflet is for Zydus amitriptyline hydrochloride film-coated tablets and must be checked against the actual pack, NDC and label version.
Markets outside the United States
Local brand, approval, pack and supply are not established by this dossierNo other-market status is inferred from the U.S. historical RLD or generic label.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Do historical ELAVIL 10/25/50/75/100/150 mg strengths tell me how many tablets to take?
No. They are only per-tablet strengths for historical products. Individual tablet counts, frequency, age, cardiac risk, co-medications and any adjustment must be decided by the prescribing team using the actual pack, prescription, test results and complete medicine list.
Are ELAVIL, amitriptyline injection and a chlordiazepoxide combination the same product?
No. This historical ELAVIL page is limited to single-ingredient oral tablets; injection has a different route and a combination contains another active ingredient. A shared medicine name is not a basis for self-substitution, combination or conversion.
What if an older adult develops drowsiness, confusion, unsteadiness or a fall?
Contact local medical services promptly and take every medicine pack and the complete list. The site cannot determine the cause, and the medicine should not be abruptly self-stopped or made up. Fainting, seizure, severe altered awareness, breathing difficulty or inability to remain safe requires local emergency services immediately.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.