What this pack is
PROGRAF is the brand name in this record; tacrolimus immediate-release capsules is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
PROGRAFGeneric nametacrolimus immediate-release capsules
How this medicine works
Tacrolimus binds intracellular FKBP-12; the resulting complex inhibits calcineurin, affects NF-AT and other signalling and multiple cytokines, and ultimately suppresses T-lymphocyte activation and proliferation. This explains the immunosuppressive direction but cannot determine an individual dose, target blood level, switch to cyclosporine or conversion to an extended-release product.
Read source: United States ↗Current regulatory record · reviewed 2026-09-04More 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
- PROGRAF
- Source-scoped market brand names
- PROGRAF · United StatesCurrent regulator record ↗Current brand label; a regulatory record does not prove live supply or individual suitability.
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
- tacrolimus immediate-release capsules
- Dosage-form class
- PROGRAF immediate-release tacrolimus hard capsules: 0.5 mg, 1 mg and 5 mg are per-capsule strengths, each shown as a 100-capsule bottle. Different strengths, immediate- versus extended-release products, and capsules versus granules or injection cannot be self-interchanged by name or milligrams.
- 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.
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 · Current U.S. DailyMed brand label (SPL v30; August 2023)
Tacrolimus 0.5 mg per capsule; 100-capsule bottle
- Product code
- NDC 0469-0607-73
- Form and route
- PROGRAF tacrolimus immediate-release hard capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- tacrolimus
- 0.5 mglabelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- light yellow · oblong hard capsule, about 11 mm · imprint f / 607 / 0.5 mgNot scored in this labelled presentation
United States label · Current U.S. DailyMed brand label (SPL v30; August 2023)
Tacrolimus 1 mg per capsule; 100-capsule bottle
- Product code
- NDC 0469-0617-73
- Form and route
- PROGRAF tacrolimus immediate-release hard capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- tacrolimus
- 1 mglabelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- white · oblong hard capsule, about 11 mm · imprint f / 617 / 1 mgNot scored in this labelled presentation
United States label · Current U.S. DailyMed brand label (SPL v30; August 2023)
Tacrolimus 5 mg per capsule; 100-capsule bottle
- Product code
- NDC 0469-0657-73
- Form and route
- PROGRAF tacrolimus immediate-release hard capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- tacrolimus
- 5 mglabelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- grayish red · oblong hard capsule, about 14 mm · imprint f / 657 / 5 mgNot scored in this labelled presentation
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
PROGRAF enlarged label: per-capsule strength, blood levels, nephrotoxicity, infection and non-interchangeability
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 0.5 mg, 1 mg and 5 mg figures are tacrolimus amounts per capsule; 100 Capsules is the bottle count. Individual capsule counts, intervals and target blood levels cannot be inferred from pack numbers. With each new supply, check brand, release form, strength, appearance and prescription; tacrolimus products must not be self-substituted.
- The label states that immediate-release PROGRAF is not interchangeable with extended-release tacrolimus. Dispensing or substitution errors have led to rejection or under-/overexposure. Contact the transplant team or pharmacist before use when ASTAGRAF XL, ENVARSUS XR, granules, injection or a different appearance is supplied.
- Tacrolimus requires whole-blood trough monitoring together with clinical context. The site cannot use one result, weight, age, genetics or pack strength to calculate capsule count, target range or adjustment.
- Nephrotoxicity, hyperkalaemia, hypomagnesaemia, hypertension, new-onset diabetes, neurotoxicity and rhythm-related risks require professional monitoring. Marked urine changes, severe headache, altered awareness or vision, seizure or another acute concern requires local urgent care and the transplant team.
- Immunosuppression increases serious and opportunistic infection, lymphoma and other malignancy risks. Fever, chills, cough, skin change or new neurological symptoms cannot be assessed by a webpage, and treatment must not be self-stopped.
- Strong CYP3A inhibitors or inducers, other nephrotoxic medicines, potassium-raising agents, live vaccines and grapefruit can alter exposure or risk. Give the pharmacist all prescriptions, OTC medicines, herbs, supplements, diet and recent changes together; do not self-separate, stop or switch.
- Capsules should not be opened or crushed. Granules have separate preparation instructions and capsule contents are not granules. Pregnancy, pregnancy planning, breastfeeding or powder exposure also requires advance professional review.
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 · 2026-09-04
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. PROGRAF tacrolimus brand label, full prescribing information and three exact capsule package panels (SPL v30; Aug 2023) ↗Current regulatory record · reviewed 2026-09-04
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 PROGRAF (tacrolimus immediate-release capsules). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
PROGRAF is the brand in this record and tacrolimus immediate-release capsules is the active-ingredient name. Check both with the dosage form (PROGRAF immediate-release tacrolimus hard capsules: 0.5 mg, 1 mg and 5 mg are per-capsule strengths, each shown as a 100-capsule bottle. Different strengths, immediate- versus extended-release products, and capsules versus granules or injection cannot be self-interchanged by name or milligrams.) 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
Mechanism reading: calcineurin inhibition does not permit mechanism-based self-switching
- The same immune purpose, pathway or generic name does not make dosage form, exposure, risks or monitoring interchangeable.
- CYP3A- and transporter-related interactions can materially change exposure, but the site generates no stopping, separation, reduction or switching plan.
- For older adults, polypharmacy, changed liver or kidney function or infection, the actual packs, prescription, blood levels and laboratory results require transplant-team review together.
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. PROGRAF tacrolimus brand label, full prescribing information and three exact capsule package panels (SPL v30; Aug 2023) ↗Current regulatory record · reviewed 2026-09-04
- FDA: PROGRAF proprietary-name review records capsule NDA 050708 approval on 8 Apr 1994 ↗reviewed 2026-09-04
SOURCE-TRACEABLE ARCHIVE
PROGRAFtacrolimus immediate-release capsules
This page includes an exact current U.S. public-label package panel for PROGRAF, 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
U.S. approval of PROGRAF capsules
The FDA review records approval of immediate-release capsules under NDA 050708 on this date.
FDA: PROGRAF proprietary-name review records capsule NDA 050708 approval on 8 Apr 1994 ↗Current DailyMed label effective
SPL v30 lists the three capsule strengths, exact packs and current safety information.
DailyMed (NLM): current U.S. PROGRAF tacrolimus brand label, full prescribing information and three exact capsule package panels (SPL v30; Aug 2023) ↗
MARKET SCOPE
Market-record boundary
United States
Current public brand labelThree exact immediate-release capsule bottles are displayed; not proof of live supply.
Mainland China and other markets
Local approval, brand, reference, pack and supply not yet established market by marketNo other-market status is inferred from the U.S. NDA, NDC or pack.
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 immediate- and extended-release tacrolimus be switched by myself?
No. The current label states they are not interchangeable; conversion requires physician supervision and monitoring including blood levels.
Does a 1 mg capsule mean one capsule each time?
No. 1 mg is the amount per capsule; the exact prescription and transplant team determine capsule count and interval using monitoring.
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.