What this pack is
RAZADYNE / RAZADYNE ER is the brand name in this record; galantamine hydrobromide immediate-release tablets and extended-release capsules is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
RAZADYNE / RAZADYNE ERGeneric namegalantamine hydrobromide immediate-release tablets and extended-release capsules
How this medicine works
The label describes galantamine as a competitive, reversible acetylcholinesterase inhibitor that enhances cholinergic function, while stating there is no evidence that it alters the underlying dementing process. Mechanism cannot replace diagnosis, benefit assessment or a care plan.
Read source: United States ↗Current regulatory record · reviewed 2026-09-06More 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
- RAZADYNE / RAZADYNE ER
- Generic name
- galantamine hydrobromide immediate-release tablets and extended-release capsules
- Dosage-form class
- Historical brand immediate-release tablets at 4/8/12 mg and extended-release capsules at 8/16/24 mg; a historical oral-solution application also exists, but this page does not yet display an exact oral-solution package panel
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
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 →
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.
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.
6 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 · Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued
Equivalent to galantamine 8 mg per capsule (supplied as galantamine hydrobromide 10.25 mg); 30-count bottle; historical brand listing discontinued
- Product code
- NDC 50458-387-30
- Form and route
- RAZADYNE ER galantamine hydrobromide extended-release capsule · oral; historical brand product-identity field
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-06; actual marketing, stock and availability are not established.
- galantamine (supplied as galantamine hydrobromide)
- 8 mglabelled amount per capsule; not an individual's count, frequency, conversion or restart instruction
- Package
- 30 capsules per bottle
- Labelled appearance
- white opaque · hard-gelatin capsule, approximately 14 mm, unscored · imprint GAL;8Capsule; tablet score status does not apply
United States label · Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued
Equivalent to galantamine 16 mg per capsule (supplied as galantamine hydrobromide 20.51 mg); 30-count bottle; historical brand listing discontinued
- Product code
- NDC 50458-388-30
- Form and route
- RAZADYNE ER galantamine hydrobromide extended-release capsule · oral; historical brand product-identity field
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-06; actual marketing, stock and availability are not established.
- galantamine (supplied as galantamine hydrobromide)
- 16 mglabelled amount per capsule; not an individual's count, frequency, conversion or restart instruction
- Package
- 30 capsules per bottle
- Labelled appearance
- pink opaque · hard-gelatin capsule, approximately 18 mm, unscored · imprint GAL;16Capsule; tablet score status does not apply
United States label · Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued
Equivalent to galantamine 24 mg per capsule (supplied as galantamine hydrobromide 30.76 mg); 30-count bottle; historical brand listing discontinued
- Product code
- NDC 50458-389-30
- Form and route
- RAZADYNE ER galantamine hydrobromide extended-release capsule · oral; historical brand product-identity field
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-06; actual marketing, stock and availability are not established.
- galantamine (supplied as galantamine hydrobromide)
- 24 mglabelled amount per capsule; not an individual's count, frequency, conversion or restart instruction
- Package
- 30 capsules per bottle
- Labelled appearance
- caramel brown opaque · hard-gelatin capsule, approximately 19 mm, unscored · imprint GAL;24Capsule; tablet score status does not apply
United States label · Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued
Equivalent to galantamine 4 mg per tablet; 60-count bottle; historical brand listing discontinued
- Product code
- NDC 50458-396-60
- Form and route
- RAZADYNE galantamine hydrobromide immediate-release film-coated tablet · oral; historical brand product-identity field
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-06; actual marketing, stock and availability are not established.
- galantamine (supplied as galantamine hydrobromide)
- 4 mglabelled amount per tablet; not an individual's count, frequency, conversion or restart instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- off-white · round biconvex film-coated tablet, approximately 5 mm, unscored · imprint JANSSEN;G;4Unscored; do not infer permission to split it
United States label · Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued
Equivalent to galantamine 8 mg per tablet; 60-count bottle; historical brand listing discontinued
- Product code
- NDC 50458-397-60
- Form and route
- RAZADYNE galantamine hydrobromide immediate-release film-coated tablet · oral; historical brand product-identity field
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-06; actual marketing, stock and availability are not established.
- galantamine (supplied as galantamine hydrobromide)
- 8 mglabelled amount per tablet; not an individual's count, frequency, conversion or restart instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- pink · round biconvex film-coated tablet, approximately 7 mm, unscored · imprint JANSSEN;G;8Unscored; do not infer permission to split it
United States label · Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued
Equivalent to galantamine 12 mg per tablet; 60-count bottle; historical brand listing discontinued
- Product code
- NDC 50458-398-60
- Form and route
- RAZADYNE galantamine hydrobromide immediate-release film-coated tablet · oral; historical brand product-identity field
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-06; actual marketing, stock and availability are not established.
- galantamine (supplied as galantamine hydrobromide)
- 12 mglabelled amount per tablet; not an individual's count, frequency, conversion or restart instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- orange-brown · round biconvex film-coated tablet, approximately 8 mm, unscored · imprint JANSSEN;G;12Unscored; do not infer permission to split it
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
RAZADYNE label reading: first separate immediate-release tablets, oral solution and ER capsules
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.
The historical brand had three oral forms, while a current U.S. generic label continues to provide safety information. This section reads product identity, pack numbers, restarting after interruption, heart-rate/fainting, weight and gastrointestinal effects together, but generates no individual dose or formulation-switch plan.
- The 4, 8 and 12 mg immediate-release tablets and 8, 16 and 24 mg ER capsules state galantamine equivalent per tablet or capsule. Bottle counts of 30 or 60 are pack quantities, not daily counts. Galantamine-hydrobromide mass and galantamine equivalent are not two medicine amounts.
- Even though official labels contain clinician-directed conversion information between tablets and ER capsules, a webpage cannot authorise self-switching forms, assembling smaller strengths or changing frequency. ER capsules, immediate-release tablets and oral solution differ in release, instructions and product identity.
- The current generic label says interruption for more than three days requires restarting at the lowest dosage and re-titration. This is not a self-restart timetable: after several missed days, hospital discharge, vomiting/dehydration or a care transition, contact the prescriber or pharmacist before resuming the old routine.
- The label describes bradycardia and heart block, syncope, nausea/vomiting/diarrhoea, reduced appetite and weight, gastrointestinal bleeding, urinary obstruction, serious skin reactions and concerns in asthma/COPD. In an older adult, fainting, falls, an abnormal pulse, persistent vomiting/diarrhoea, black stool/vomiting blood, widespread blistering rash, breathing difficulty or marked dehydration needs prompt local medical care; severe acute features require emergency help.
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 · 2026-09-06
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 · 3
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 label for galantamine extended-release capsules (revised Dec 2023; updated 12 Aug 2024) ↗Current regulatory record · reviewed 2026-09-06
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.
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-06DailyMed (NLM): historical U.S. RAZADYNE / RAZADYNE ER brand label (Janssen; SPL v25; effective 11 Oct 2022) ↗reviewed 2026-09-06
- FDA · United States · Regulatory product record or label archive · 2026-09-06FDA: 2015 U.S. prescribing information for RAZADYNE ER NDA 021615 ↗reviewed 2026-09-06
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 RAZADYNE / RAZADYNE ER (galantamine hydrobromide immediate-release tablets and extended-release capsules). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
RAZADYNE / RAZADYNE ER is the brand in this record and galantamine hydrobromide immediate-release tablets and extended-release capsules is the active-ingredient name. Check both with the dosage form (Historical brand immediate-release tablets at 4/8/12 mg and extended-release capsules at 8/16/24 mg; a historical oral-solution application also exists, but this page does not yet display an exact oral-solution package panel) 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 label for galantamine extended-release capsules (revised Dec 2023; updated 12 Aug 2024) ↗Current regulatory record · reviewed 2026-09-06
- DailyMed (NLM): historical U.S. RAZADYNE / RAZADYNE ER brand label (Janssen; SPL v25; effective 11 Oct 2022) ↗reviewed 2026-09-06
- FDA: 2015 U.S. prescribing information for RAZADYNE ER NDA 021615 ↗reviewed 2026-09-06
HOW IT WORKS · NOT A TREATMENT PLAN
How galantamine works: reversible acetylcholinesterase inhibition does not alter the course of dementia
- Donepezil, rivastigmine and galantamine are related cholinesterase-inhibitor treatments but are not one medicine that can be self-converted by milligrams, alternated or combined; memantine has another mechanism. Review the full medicine list and exact products before addressing duplication or a switch.
- Anticholinergic medicines may oppose galantamine, while other cholinesterase inhibitors, cholinergic agonists and some neuromuscular blockers used in anaesthesia require priority review. Show the complete medicine list before care or surgery; do not self-separate or stop medicines from the page.
- CYP2D6 genetic variation can affect exposure, but the label does not require whole-genome screening for everyone or automatic dose changes from poor-metaboliser status alone. Genetic information, kidney/liver function, tolerability and interactions require interpretation by the responsible team for the actual question.
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.
- DailyMed (NLM): historical U.S. RAZADYNE / RAZADYNE ER brand label (Janssen; SPL v25; effective 11 Oct 2022) ↗reviewed 2026-09-06
- DailyMed (NLM): current U.S. generic label for galantamine extended-release capsules (revised Dec 2023; updated 12 Aug 2024) ↗Current regulatory record · reviewed 2026-09-06
- FDA: RLD/RS identities and discontinued status for galantamine tablets NDA 021169 and RAZADYNE ER NDA 021615 (2025 Chemistry Review) ↗reviewed 2026-09-06
- FDA: application history and discontinued status of RAZADYNE brand tablets, oral solution and extended-release capsules (2025 Medical Review) ↗reviewed 2026-09-06
- FDA: 2015 U.S. prescribing information for RAZADYNE ER NDA 021615 ↗reviewed 2026-09-06
SOURCE-TRACEABLE ARCHIVE
RAZADYNE / RAZADYNE ERgalantamine hydrobromide immediate-release tablets and extended-release capsules
This page links to public primary-source material for RAZADYNE / RAZADYNE ER. 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 U.S. marketing-start record for RAZADYNE tablets
DailyMed product tables for 4, 8 and 12 mg tablets list NDA 021169 and 1 Mar 2001; FDA's 2025 review says the brand tablets are no longer marketed.
DailyMed (NLM): historical U.S. RAZADYNE / RAZADYNE ER brand label (Janssen; SPL v25; effective 11 Oct 2022) ↗Historical U.S. marketing-start record for RAZADYNE ER
All three ER capsule product tables list NDA 021615 and 24 Dec 2004; brand-pack marketing end dates fall in Apr-May 2023.
DailyMed (NLM): historical U.S. RAZADYNE / RAZADYNE ER brand label (Janssen; SPL v25; effective 11 Oct 2022) ↗FDA review confirms discontinued brand forms and RLD/RS identities
The Chemistry Review lists the 4/8/12 mg tablets and 8/16/24 mg ER capsules as RLD/RS and discontinued; the Medical Review also says the brand oral-solution application is no longer marketed.
FDA: RLD/RS identities and discontinued status for galantamine tablets NDA 021169 and RAZADYNE ER NDA 021615 (2025 Chemistry Review) ↗
MARKET SCOPE
Market-record boundary
United States
Historical brand forms discontinued; current generic label records existThe page shows six exact historical brand pack images and separately links a current generic safety label. They do not establish current brand stock, purchase eligibility or automatic substitution.
Mainland China, EU, Japan and other markets
Exact market-product records not establishedNo local trade name, approval, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. RAZADYNE/REMINYL names, NDA, colour, imprint or shared generic name.
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.
RECORD FAQ
Record questions
Can two RAZADYNE ER 8 mg capsules self-replace one 16 mg capsule?
A webpage cannot authorise this. Arithmetic does not establish an equivalent prescription, pack, availability or individual safety. After missed days or before a strength change, ask the pharmacist or prescriber to review the exact product and plan.
Why does the pack say 16 mg and also 20.51 mg hydrobromide?
16 mg is the galantamine active-moiety equivalent per capsule; 20.51 mg is the mass of galantamine hydrobromide salt supplying it. They are two expressions for the same capsule, not 36.51 mg in total and not two doses.
Can galantamine be self-combined or switched with donepezil or memantine?
No. Mechanisms, dosage forms, interactions and individual circumstances differ. The site only prompts medicine-list review and provides no combination, stopping, switching or timing plan. A professional familiar with the history and complete list should decide.
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.