What this pack is
Baraclude is the brand name in this record; entecavir is the generic name. Read both together with the dosage form (multiple oral forms (tablets and oral liquid)).
PACK CHECK · MARKET FIRST
BaracludeGeneric nameentecavir
Mainland China pack-name cue博路定®Historical or public source cue · verify the current target-market record · Open reference ↗
How this medicine works
The DailyMed label explains that entecavir is a deoxyguanosine nucleoside analogue active against hepatitis B virus reverse transcriptase. After phosphorylation to its active triphosphate form, it competitively affects multiple reverse-transcriptase activities. This explains a pharmacologic pathway; it does not predict an individual's virologic markers, suitability, course, tablet count or stopping time.
Read source: United States ↗reviewed 2026-08-20More 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.
- Mainland China pack-name cue
- 博路定®
- International brand name
- Baraclude
- Generic name
- entecavir
- Dosage-form class
- Film-coated oral tablets (0.5 mg and 1 mg) and ready-to-use oral solution (0.05 mg/mL), as listed in the dated U.S. public label
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
Mainland China trade-name search cue:博路定®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility. Open reference ↗
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 →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
The 0.5 mg and 1 mg tablet labels and the oral solution's 0.05 mg/mL concentration are different labelled product identities. They never create a tablet-to-millilitre conversion, individual amount, course, measuring-device instruction, stopping or switching plan.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
3 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability
0.5 mg per tablet; 30-tablet child-resistant bottle
- Product code
- NDC 0003-1611-12
- Form and route
- BARACLUDE entecavir oral film-coated tablet · oral
- Container
- child-resistant bottle
- Listing review
- Cited product evidence reviewed 2026-08-21; actual marketing, stock and availability are not established.
- entecavir
- 0.5 mglabelled amount per tablet; not an individual's tablet count, course or self-conversion to oral solution
- Package
- 30 tablets per bottle
- Labelled appearance
- white to off-white · triangular film-coated tablet · imprint BMS / 1611Unscored in this labelled presentation
United States label · DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability
1 mg per tablet; 30-tablet child-resistant bottle
- Product code
- NDC 0003-1612-12
- Form and route
- BARACLUDE entecavir oral film-coated tablet · oral
- Container
- child-resistant bottle
- Listing review
- Cited product evidence reviewed 2026-08-21; actual marketing, stock and availability are not established.
- entecavir
- 1 mglabelled amount per tablet; not an individual's tablet count, course or self-conversion to 0.5 mg tablets/oral solution
- Package
- 30 tablets per bottle
- Labelled appearance
- pink · triangular film-coated tablet · imprint BMS / 1612Unscored in this labelled presentation
United States label · DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability
0.05 mg/mL; 210 mL child-resistant bottle
- Product code
- NDC 0003-1614-12
- Form and route
- BARACLUDE entecavir ready-to-use oral solution · oral
- Labelled concentration
- 0.05 mg/mL (labelled concentration; not an individual's millilitres)Product identity, not an individual dose
- Container
- child-resistant bottle · 210 mL
- Listing review
- Cited product evidence reviewed 2026-08-21; actual marketing, stock and availability are not established.
- entecavir
- 0.05 mglabelled concentration; not an individual's millilitres, measuring-device instruction or self-conversion to tablets
- Package
- 1 bottle per carton
PUBLIC LABEL IMAGE
Appearance and package-text clues
This dated or historical public-label image is for checking the brand, generic-name, strength and dosage-form clues only. It does not authenticate a product or establish originator status, a current label, current packaging, target-market approval or sale eligibility.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
BARACLUDE label reading: tablets, oral solution and why not to self-stop
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.
This module uses the U.S. DailyMed BARACLUDE public label as a reading entry point. It helps check the brand, entecavir, tablet/oral solution, 0.5 mg, 1 mg, 0.05 mg/mL and package text; it does not convert these into anyone's treatment, switch, dose change or stopping plan.
- 0.5 mg and 1 mg are labelled tablet strengths; 0.05 mg/mL is the oral-solution concentration. mg, mg/mL, tablet count and millilitre amount are not the same unit and cannot be self-converted, substituted or adjusted because package numbers look similar.
- The DailyMed 0.5 mg tablet image only corresponds to that one representative U.S. package. It cannot confirm the appearance, approval status or authenticity of another market, strength, oral solution or generic product.
- The label warns that severe acute exacerbations can occur after anti-hepatitis B therapy is stopped. With a missed dose, a wish to stop, a product change or symptoms, take the actual package and complete medicine list to the prescribing team or pharmacist; do not decide the next step from a webpage or package image.
- The label includes kidney-function-related product information and notes circumstances involving some post-transplant or immunosuppressive treatment that require professional assessment. Age, conditions or concomitant medicines cannot be converted by a webpage into an individual regimen; a professional must check the exact product and current label.
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 · 2026-08-20
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): dated U.S. BARACLUDE public label (tablets, oral solution and package panels; SPL v42) ↗reviewed 2026-08-20
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 · 2026-08-20FDA: BARACLUDE 2018 U.S. label ↗Historical public record · reviewed 2026-08-20
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 Baraclude (entecavir). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Baraclude is the brand in this record and entecavir is the active-ingredient name. Check both with the dosage form (Film-coated oral tablets (0.5 mg and 1 mg) and ready-to-use oral solution (0.05 mg/mL), as listed in the dated U.S. public 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): dated U.S. BARACLUDE public label (tablets, oral solution and package panels; SPL v42) ↗reviewed 2026-08-20
- FDA: BARACLUDE 2018 U.S. label ↗Historical public record · reviewed 2026-08-20
HOW IT WORKS · NOT A TREATMENT PLAN
How entecavir works: it affects multiple steps of hepatitis B virus reverse transcriptase inside cells
- ‘Affects hepatitis B virus reverse transcriptase’ describes one replication-related pathway only; it cannot determine anyone's infection stage, laboratory result or whether treatment should start, continue or stop.
- Tablets and oral solution can contain the same active ingredient while having different forms, labelled units and current-label information. A shared mechanism does not make them products that can be self-converted by tablet count or millilitres, alternated or substituted.
- A mechanism page also cannot resolve decisions about missed doses, stopping, combinations or post-transplant use. Such questions require the current target-market label and professional review by someone familiar with the complete medicine list and clinical context.
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: BARACLUDE 2018 U.S. label ↗Historical public record · reviewed 2026-08-20
- DailyMed (NLM): dated U.S. BARACLUDE public label (tablets, oral solution and package panels; SPL v42) ↗reviewed 2026-08-20
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Baracludeentecavir
This page links to public primary-source material for Baraclude. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
LABEL USE SNAPSHOT
What the cited U.S. label covers
U.S. FDA label snapshot, revised Jun 2018: for chronic hepatitis B virus infection in adults and children at least 2 years old with active viral replication and evidence of persistent aminotransferase elevation or histologically active disease. This is a historical label snapshot.
It is source-reading context, not an individual diagnosis, prescription, substitution or purchasing recommendation. Check the current label in the target market.
DOCUMENT TIMELINE
Document timeline
U.S. public historical-material entry point
This archive uses FDA public material for Baraclude® as a historical reading entry point; approval number and specific product document must be checked record by record in the database.
FDA Drugs@FDA search ↗FDA label archive version
This page links the Jun 2018 FDA label archive; all current information needs review against the target market’s current record.
FDA: Baraclude prescribing information ↗DailyMed SPL v42 dated label version
BARACLUDE DailyMed SPL v42 is marked effective 6 Nov 2019 and listed in the media directory as published 22 Dec 2025. It supports this page's three exact package panels; it does not establish current supply or another-market status.
DailyMed (NLM): dated U.S. BARACLUDE public label (tablets, oral solution and package panels; SPL v42) ↗
MARKET SCOPE
Market-record boundary
United States
Public label archive linkedThis page establishes only a document-reading path.
Mainland China, EU, Japan
Market record not establishedNo local product status is inferred from the U.S. label archive.
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.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
Mainland China trade-name search cue: 博路定®
This cue helps read packaging and search official records. It does not establish current approval, holder, strength, originator relationship, supply or sale eligibility. Open historical reference ↗
RECORD FAQ
Record questions
Can a historical label decide actual use?
No. Historical material is for understanding sources; individual use and current safety information require the latest target-market label and professional advice.
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.