What this pack is
NovoNorm / PRANDIN is the brand name in this record; repaglinide is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
NovoNorm / PRANDINGeneric namerepaglinide
How this medicine works
The EMA label says repaglinide closes ATP-dependent potassium channels in pancreatic beta-cell membranes, depolarising the cells, opening calcium channels and stimulating insulin release. This depends on functioning beta cells. The mechanism cannot interpret one glucose result or choose a combination, switch or strength for an individual.
Read source: Europe ↗Current regulatory record · reviewed 2026-08-31More 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
- NovoNorm / PRANDIN
- Source-scoped market brand names
- NovoNorm · Source-scoped evidence ↗
- Prandin · Source-scoped evidence ↗
- PRANDIN · Source-scoped evidence ↗
- NovoNorm · Source-scoped evidence ↗
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
- repaglinide
- Dosage-form class
- Oral tablets: 0.5 mg, 1 mg and 2 mg are amounts of repaglinide per tablet, not a tablet count per administration. EMA product information lists aluminium/aluminium blister packs of 30, 90, 120 or 270 tablets and states that not all pack sizes may be marketed. This site does not turn a pack count into individual instructions.
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
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.
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.
EU · Current public EMA product information
0.5 mg repaglinide per tablet; white round convex tablet engraved with the Novo Nordisk logo; not an individual's tablet count
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- EMEA/H/C/000187
- Form and route
- NovoNorm repaglinide 0.5 mg oral tablet · oral
- Listing review
- Cited public label display reviewed 2026-08-31; actual marketing, stock and availability are not established.
- repaglinide
- 0.5 mglabelled amount per tablet; not an individual's frequency or meal schedule
EU · Current public EMA product information
1 mg repaglinide per tablet; yellow round convex tablet engraved with the Novo Nordisk logo; not an individual's tablet count
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- EMEA/H/C/000187
- Form and route
- NovoNorm repaglinide 1 mg oral tablet · oral
- Listing review
- Cited public label display reviewed 2026-08-31; actual marketing, stock and availability are not established.
- repaglinide
- 1 mglabelled amount per tablet; not an individual's frequency or meal schedule
EU · Current public EMA product information
2 mg repaglinide per tablet; peach-coloured round convex tablet engraved with the Novo Nordisk logo; not an individual's tablet count
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- EMEA/H/C/000187
- Form and route
- NovoNorm repaglinide 2 mg oral tablet · oral
- Listing review
- Cited public label display reviewed 2026-08-31; actual marketing, stock and availability are not established.
- repaglinide
- 2 mglabelled amount per tablet; not an individual's frequency or meal schedule
United States label · Historical brand record in the current FDA Orange Book dataset
0.5 mg repaglinide per tablet; historical RLD, currently DISCN
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020741 / Product 001
- Form and route
- PRANDIN repaglinide 0.5 mg oral tablet · oral
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- repaglinide
- 0.5 mgamount per historical product tablet; does not establish current brand stock
United States label · Historical brand record in the current FDA Orange Book dataset
1 mg repaglinide per tablet; historical RLD, currently DISCN
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020741 / Product 002
- Form and route
- PRANDIN repaglinide 1 mg oral tablet · oral
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- repaglinide
- 1 mgamount per historical product tablet; does not establish current brand stock
United States label · Historical brand record in the current FDA Orange Book dataset
2 mg repaglinide per tablet; historical RLD, currently DISCN
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020741 / Product 003
- Form and route
- PRANDIN repaglinide 2 mg oral tablet · oral
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- repaglinide
- 2 mgamount per historical product tablet; does not establish current brand stock
PACKAGE-VISUAL STATUS
Official tablet appearance text is available, but no current official principal pack image was obtained one-to-one for all six identities
The EMA label describes round convex tablets engraved with the Novo Nordisk logo: white for 0.5 mg, yellow for 1 mg and peach-coloured for 2 mg. Colour and logo are supporting clues only for the exact EU product. Historical U.S. PRANDIN, China-market NovoNorm and packs from other periods may differ, so appearance alone cannot establish authenticity.
LABEL READING · NOT A PRESCRIPTION
NovoNorm enlarged label: per-tablet strength, meal-related wording, hypoglycaemia and interactions
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 label links repaglinide to main meals, but this site does not generate an individual clock time, missed-meal rule or make-up instruction. Check the exact pack, prescription and current label with the prescriber or pharmacist. Confusion, seizure, unconsciousness or concern about severe hypoglycaemia requires immediate local emergency help.
- 0.5 mg, 1 mg and 2 mg are amounts per tablet, not tablets per meal. Different strengths, markets and packs must not be assembled or interchanged from numbers alone.
- The label contains pre-meal and missed-meal wording, but meal patterns, glucose, prescriptions and co-medications differ. The site prompts verification and does not generate a meal-time or missed-dose plan.
- Repaglinide can cause hypoglycaemia. Sweating, tremor, dizziness, headache or behavioural or awareness change requires prompt action under the individual's established professional emergency plan and clinical contact. Seizure, loss of consciousness or coma requires immediate local emergency help.
- Gemfibrozil co-use is contraindicated by the label. Clopidogrel may substantially increase repaglinide exposure; metformin or another glucose-lowering medicine can increase hypoglycaemia risk; beta blockers may mask hypoglycaemia signals. Review the full medicine list and do not self-stop, switch or separate medicines.
- Severe hepatic dysfunction is contraindicated. Frailty, malnutrition, liver or kidney problems and age over 75 require professional review. The label says no clinical studies were conducted above age 75; the site does not convert age into a strength.
- PRANDIMET contains both repaglinide and metformin and is a different combination product. It must not be combined with single-ingredient NovoNorm or PRANDIN by brand name.
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 checkEMA · European Union / European Economic Area · Regulatory product record or EU product information · 2026-08-31
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
- European Union / European Economic Area · 3
- 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 routeEMA: EU product information for NovoNorm (repaglinide) ↗Current regulatory record · reviewed 2026-08-31
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.
- EMA · European Union / European Economic Area · Regulatory product record or EU product information · 2026-08-31EMA: authorised NovoNorm repaglinide EPAR record ↗Current regulatory record · reviewed 2026-08-31
- EMA · European Union / European Economic Area · Regulatory product record or EU product information · 2026-08-31EMA: authorised Prandin repaglinide EPAR record ↗Current regulatory record · reviewed 2026-08-31
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Orange Book: historical PRANDIN / repaglinide RLD records under NDA 020741 ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about NovoNorm / PRANDIN (repaglinide). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
NovoNorm / PRANDIN is the brand in this record and repaglinide is the active-ingredient name. Check both with the dosage form (Oral tablets: 0.5 mg, 1 mg and 2 mg are amounts of repaglinide per tablet, not a tablet count per administration. EMA product information lists aluminium/aluminium blister packs of 30, 90, 120 or 270 tablets and states that not all pack sizes may be marketed. This site does not turn a pack count into individual instructions.) 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.
- EMA: EU product information for NovoNorm (repaglinide) ↗Current regulatory record · reviewed 2026-08-31
- EMA: authorised NovoNorm repaglinide EPAR record ↗Current regulatory record · reviewed 2026-08-31
- EMA: authorised Prandin repaglinide EPAR record ↗Current regulatory record · reviewed 2026-08-31
- FDA Orange Book: historical PRANDIN / repaglinide RLD records under NDA 020741 ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How repaglinide works: a short-acting insulin secretagogue, not insulin itself
- Repaglinide is not insulin and is not for type 1 diabetes or diabetic ketoacidosis.
- Repaglinide, sulfonylureas and nateglinide may all promote insulin release, but their targets, products and evidence differ. A related class or mechanism does not permit self-conversion, combination or rotation by milligrams.
- The label describes interactions involving CYP2C8, CYP3A4 and OATP1B1. This does not mean everyone needs whole-genome testing, and the site does not calculate a plan from genes or medicine names.
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.
- EMA: EU product information for NovoNorm (repaglinide) ↗Current regulatory record · reviewed 2026-08-31
- EMA: authorised NovoNorm repaglinide EPAR record ↗Current regulatory record · reviewed 2026-08-31
- EMA: authorised Prandin repaglinide EPAR record ↗Current regulatory record · reviewed 2026-08-31
- FDA Orange Book: historical PRANDIN / repaglinide RLD records under NDA 020741 ↗reviewed 2026-08-29
- Jining Municipal Government: NovoNorm / repaglinide-tablet name and strength cue in a 2026 public medicine-price page ↗reviewed 2026-08-31
SOURCE-TRACEABLE ARCHIVE
NovoNorm / PRANDINrepaglinide
This page links to public primary-source material for NovoNorm / PRANDIN. 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
Initial U.S. approval of PRANDIN
The FDA Orange Book records historical 0.5, 1 and 2 mg RLD products under NDA 020741; all are currently DISCN.
FDA Orange Book: historical PRANDIN / repaglinide RLD records under NDA 020741 ↗Initial EU authorisation of NovoNorm
EMA product information records the initial authorisation date as 17 August 1998.
EMA: EU product information for NovoNorm (repaglinide) ↗EU authorisation of Prandin
EMA retains a separate authorised Prandin EPAR record.
EMA: authorised Prandin repaglinide EPAR record ↗China government page shows a dated NovoNorm name and strength cue
The page lists NovoNorm/repaglinide tablets at 1 mg × 30 and 2 mg × 30. It is only a dated name cue and does not establish current NMPA status or stock.
Jining Municipal Government: NovoNorm / repaglinide-tablet name and strength cue in a 2026 public medicine-price page ↗
MARKET SCOPE
Market-record boundary
European Union
Current authorised NovoNorm and Prandin recordsEMA publicly retains two non-generic EPAR product records; actual supply still requires country-specific checking.
United States
Historical RLD; currently DISCNThe 0.5, 1 and 2 mg brand rows are discontinued, with public records indicating no safety-or-effectiveness withdrawal; this does not establish current brand stock.
China
Dated government public-name cueThe NovoNorm name can start search and pack checking. NMPA approval number, current label, stock and authenticity still require item-by-item official verification.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Can two 0.5 mg tablets be self-replaced by one 1 mg tablet?
Do not make an arithmetic substitution. Even when the labelled total matches, the exact product, prescription, pack, market and individual plan still require pharmacist or prescriber review.
Can the website tell me what to do if I do not eat?
The site cannot generate an individual instruction. The label links repaglinide to main meals, but use the exact prescription and current pack label and contact a pharmacist or prescriber. If it was already taken and hypoglycaemia is a concern, follow the established professional emergency plan promptly; severe symptoms require immediate local emergency help.
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.