What this pack is
MACROBID is the brand name in this record; nitrofurantoin monohydrate/macrocrystals is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
MACROBIDGeneric namenitrofurantoin monohydrate/macrocrystals
How this medicine works
The current U.S. label describes two nitrofurantoin forms in each MACROBID capsule: the macrocrystal portion dissolves and absorbs more slowly than monohydrate, while the monohydrate powder blend forms a gel matrix in gastric and intestinal fluids that releases nitrofurantoin over time. This explains formulation reading, not individual effect, urine-colour change, capsule count, course or a switch plan.
Read source: United States ↗Current regulatory record · 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.
- International brand name
- MACROBID
- Generic name
- nitrofurantoin monohydrate/macrocrystals
- Dosage-form class
- Hard-gelatin oral capsule: 100 mg total nitrofurantoin per capsule, comprising 25 mg macrocrystals and 75 mg monohydrate; limited to the U.S. label panel cited in this dossier
- 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.
1 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 v26, published 17 Nov 2025; page updated 14 Oct 2025
100 mg total nitrofurantoin per capsule: 25 mg macrocrystals + 75 mg monohydrate; 100-capsule bottle
- Product code
- NDC 52427-285-01
- Form and route
- MACROBID nitrofurantoin monohydrate/macrocrystals hard gelatin oral capsule · oral
- Container
- 100-capsule bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- nitrofurantoin macrocrystals
- 25 mgmacrocrystal portion per labelled capsule; not an individual capsule count or conversion
- nitrofurantoin monohydrate
- 75 mgmonohydrate portion per labelled capsule; not an individual capsule count or conversion
- Package
- 100 capsules per bottle
- Labelled appearance
- opaque black and yellow · hard gelatin capsule · imprint Macrobid / 52427-285
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
MACROBID label reading: 100 mg is the total per capsule; 25 mg + 75 mg are two forms in that same capsule
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 reads only MACROBID, its two nitrofurantoin forms, total per capsule, exact NDC, 100-capsule bottle and oral-capsule form in the current U.S. DailyMed public label. It provides no individual capsule count, course, missed-use handling, start, stop, co-use, switch or purchase plan.
- Check MACROBID, nitrofurantoin monohydrate/macrocrystals, 100 mg total per capsule, NDC 52427-285-01, 100-capsule bottle, hard-gelatin oral capsule and target market together. Seeing only “nitrofurantoin” or “100 mg” does not prove another formulation, package or market product is the same.
- The label's 25 mg macrocrystals + 75 mg monohydrate are two parts of one MACROBID capsule; they are not two capsules, two uses, or a rule for mentally assembling another 25 mg, 50 mg or 100 mg nitrofurantoin capsule.
- MACRODANTIN and products labelled only “nitrofurantoin macrocrystals” are not this two-form MACROBID capsule. A shared active ingredient, a similar milligram number or “urinary antibacterial” wording is not enough to decide self-substitution, alternation or combination.
- An antibacterial label's scope, duration, food instructions, kidney function, prior reactions and complete medicine list must be handled through the exact prescription and current target-market label. With fever, flank or back pain, nausea/vomiting, rash, breathing trouble, jaundice-like changes or another acute concern, use local medical and prescribing-team pathways; do not self-start, extend, repeat, stop or switch from a webpage.
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 · 1
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. MACROBID nitrofurantoin monohydrate/macrocrystals public label (Almatica Pharma; SPL v26) ↗Current regulatory 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 MACROBID (nitrofurantoin monohydrate/macrocrystals). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
MACROBID is the brand in this record and nitrofurantoin monohydrate/macrocrystals is the active-ingredient name. Check both with the dosage form (Hard-gelatin oral capsule: 100 mg total nitrofurantoin per capsule, comprising 25 mg macrocrystals and 75 mg monohydrate; limited to the U.S. label panel cited in this dossier) 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.
HOW IT WORKS · NOT A TREATMENT PLAN
How MACROBID's two forms inform release reading: slower dissolution and gel-matrix release do not permit self-conversion
- “Slower dissolution,” “gel matrix” and “releases over time” describe the pharmaceutic pathway of this exact labelled formulation; they do not mean “stronger,” “safer,” or that a capsule may be opened, halved or converted to another formulation.
- Sharing nitrofurantoin, a 100 mg marking or a similar urinary indication does not make a two-form capsule, a macrocrystal-only capsule, another brand or another-market product suitable for self-alternation, combination or substitution.
- Mechanism and packaging also cannot determine whether a urinary symptom needs an antibacterial, which product fits, whether use continues or when it changes. With worsening symptoms, fever, flank/back pain, a severe allergy-like reaction, breathing trouble or another acute concern, use timely local medical support.
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): current U.S. MACROBID nitrofurantoin monohydrate/macrocrystals public label (Almatica Pharma; SPL v26) ↗Current regulatory record · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
MACROBIDnitrofurantoin monohydrate/macrocrystals
This page includes an exact current U.S. public-label package panel for MACROBID, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Current DailyMed page updated
The current MACROBID page lists an update date of 14 Oct 2025. This date only locates the linked U.S. public label; it does not establish approval, supply, purchase eligibility, originator/generic relationship or individual-use conclusions in another market.
DailyMed (NLM): current U.S. MACROBID nitrofurantoin monohydrate/macrocrystals public label (Almatica Pharma; SPL v26) ↗Current DailyMed SPL v26 published
The current label record lists SPL v26 as published on 17 Nov 2025. The page shows only the NDC 52427-285-01 100-capsule bottle panel to check the two nitrofurantoin forms and package identity; it does not establish actual availability, stock, purchase, individual capsule count, course, switching or interchangeability.
DailyMed (NLM): current U.S. MACROBID nitrofurantoin monohydrate/macrocrystals public label (Almatica Pharma; SPL v26) ↗
MARKET SCOPE
Market-record boundary
United States
Current public label and one exact 100-capsule bottle panel linkedThis panel corresponds to NDC 52427-285-01 and describes only the label identity of the two-form MACROBID capsule. It does not authenticate a product or establish actual availability, stock, purchase, individual capsule count, course, initiation, stopping, co-use, switching or interchangeability.
Mainland China, EU, Japan and other markets
Current market record not establishedNo local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDC or brand name; every market needs separate checking against current local regulatory material.
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
MACROBID 100 mg and MACRODANTIN 50 mg or 100 mg all name nitrofurantoin. Can they be self-converted by milligrams?
No. The current MACROBID label describes a two-form capsule containing 25 mg macrocrystals and 75 mg monohydrate, and notes comparable urinary-excretion data with certain MACRODANTIN capsules. That is not a rule for self-conversion, switching, alternating, combining or deciding a course. The exact formulations, prescribing purpose, kidney function, prior reactions and complete medicine list require pharmacist or prescriber review.
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.