What this pack is
Rybelsus is the brand name in this record; oral semaglutide is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
RybelsusGeneric nameoral semaglutide
How this medicine works
The current label describes oral semaglutide as a GLP-1 analogue and GLP-1 receptor agonist, involving glucose-dependent insulin secretion, glucagon secretion and gastric emptying. This is a mechanism overview, not an individual's glucose outcome, suitability, dose, meal plan or switching plan.
Read source: United States ↗reviewed 2026-08-23More 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
- Rybelsus
- Generic name
- oral semaglutide
- Dosage-form class
- Oral semaglutide tablets; formulations, strengths and packs require separate checking (current U.S. 2026 label)
- 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.
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 public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability
Semaglutide 3 mg per tablet; 30-tablet bottle
- Product code
- NDC 0169-4303-30
- Form and route
- RYBELSUS oral semaglutide tablet · oral (label product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-23; actual marketing, stock and availability are not established.
- semaglutide
- 3 mglabelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- white to light yellow · oval tablet; no score · imprint 3 / novo
United States label · Current U.S. DailyMed public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability
Semaglutide 7 mg per tablet; 30-tablet bottle
- Product code
- NDC 0169-4307-30
- Form and route
- RYBELSUS oral semaglutide tablet · oral (label product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-23; actual marketing, stock and availability are not established.
- semaglutide
- 7 mglabelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- white to light yellow · oval tablet; no score · imprint 7 / novo
United States label · Current U.S. DailyMed public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability
Semaglutide 14 mg per tablet; 30-tablet bottle
- Product code
- NDC 0169-4314-30
- Form and route
- RYBELSUS oral semaglutide tablet · oral (label product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-23; actual marketing, stock and availability are not established.
- semaglutide
- 14 mglabelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- white to light yellow · oval tablet; no score · imprint 14 / novo
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
RYBELSUS label reading: oral tablets, formulation and milligrams must be checked together
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module uses the FDA 2026 label and the current DailyMed public label as reading entries. It helps check RYBELSUS's oral route, full brand name, formulation cue, labelled strength per tablet and pack; it does not provide an individual starting, escalation, missed-use, injection-to-oral conversion or switching plan.
- Check RYBELSUS, semaglutide, oral tablet, labelled strength per tablet, pack and target market together. A shared generic name does not make it the same product as OZEMPIC injection, WEGOVY or another oral tablet for self-switching by name or photo.
- The current U.S. label lists different formulations and tablet strengths and states that they are not self-substitutable milligram for milligram. A number on the pack is an identity clue, not an instruction to convert, combine, split, make up or change products.
- “Oral” also does not provide a self-made schedule with other oral medicines, drinks, meals or an injection product. The current label for the actual product, prescription, complete medicine list and pharmacist/prescribing-team guidance must be reviewed together.
- For persistent vomiting, marked dehydration, severe abdominal pain, low-glucose-like symptoms or uncertainty about the product in hand, use local medical channels or contact a pharmacist/prescribing team; a webpage does not replace urgent judgement.
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 checkFDA · United States · Regulatory product record or label archive · 2026-08-20
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeFDA: RYBELSUS / OZEMPIC oral semaglutide tablets 2026 U.S. prescribing information (NDA 213051) ↗reviewed 2026-08-20
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-23DailyMed (NLM): current RYBELSUS / OZEMPIC oral semaglutide tablets public label (page updated 30 Jan 2026; label revised Jan 2026) ↗reviewed 2026-08-23
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 Rybelsus (oral semaglutide). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Rybelsus is the brand in this record and oral semaglutide is the active-ingredient name. Check both with the dosage form (Oral semaglutide tablets; formulations, strengths and packs require separate checking (current U.S. 2026 label)) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
CO-MEDICATION REVIEW · NOT A TREATMENT DECISION
When OZEMPIC / semaglutide injection is on the same list: products containing semaglutide need a complete medicine-list review
The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine.
Open the Ozempic / semaglutide record →
Add both records to this device's family medicine list →
Open the primary source for this co-medication review cue ↗reviewed 2026-08-20CO-MEDICATION REVIEW · NOT A TREATMENT DECISION
When WEGOVY / semaglutide product is on the same list: products containing semaglutide need a complete medicine-list review
The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine.
Open the Wegovy / semaglutide record →
Add both records to this device's family medicine list →
Open the primary source for this co-medication review cue ↗reviewed 2026-08-20HOW IT WORKS · NOT A TREATMENT PLAN
How oral semaglutide works: a GLP-1 pathway does not make products self-convertible
- GLP-1 is an action-pathway clue; it does not make every same-class, same-name or same-generic product self-combinable, alternatable or milligram-equivalent.
- The label's discussion of gastric emptying explains why co-administered oral medicines and actual meal timing need professional review; it cannot generate self-made spacing, stopping, make-up or adjustment rules for other medicines.
- Mechanism is not an individual prediction of benefit or adverse effects. Gastrointestinal symptoms, dehydration, kidney function, other glucose-lowering medicines and the complete medicine list require the current label for the exact product and professional assessment.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- FDA: RYBELSUS NDA 213051 original approval material (20 Sep 2019) ↗Historical public record · reviewed 2026-08-20
- FDA: RYBELSUS / OZEMPIC oral semaglutide tablets 2026 U.S. prescribing information (NDA 213051) ↗reviewed 2026-08-20
- DailyMed (NLM): current RYBELSUS / OZEMPIC oral semaglutide tablets public label (page updated 30 Jan 2026; label revised Jan 2026) ↗reviewed 2026-08-23
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Rybelsusoral semaglutide
This page links to public primary-source material for Rybelsus. 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
Original U.S. RYBELSUS approval
FDA original-approval material records approval of RYBELSUS (oral semaglutide tablets), NDA 213051, on 20 Sep 2019. This historical entry does not establish current labeling, availability, holder or another-market status.
FDA: RYBELSUS NDA 213051 original approval material (20 Sep 2019) ↗FDA current oral-tablet prescribing information revised
The linked FDA prescribing information is revised January 2026 and covers RYBELSUS and OZEMPIC tablets in one document. Check the complete brand, oral-tablet formulation, strength, pack and target market; a shared generic name does not establish interchangeability.
FDA: RYBELSUS / OZEMPIC oral semaglutide tablets 2026 U.S. prescribing information (NDA 213051) ↗Current DailyMed SPL v13 published
The DailyMed media listing shows current SPL v13 published on 20 May 2026 and includes the exact RYBELSUS 3 mg carton panel. That date and image do not establish another pack, another market or actual availability.
DailyMed (NLM): current RYBELSUS / OZEMPIC oral semaglutide tablets public label (SPL v13, published 20 May 2026) ↗
MARKET SCOPE
Market-record boundary
United States
FDA original approval, current oral-tablet label and one exact 3 mg carton panel linkedThe image corresponds only to RYBELSUS 3 mg, NDC 0169-4303-30 and a 30-tablet carton; it does not establish other strengths, R2 formulation, OZEMPIC tablets/injection, WEGOVY or actual availability.
Mainland China, EU, Japan and other markets
Market record not establishedNo local trade name, approval, pack, supply, originator relationship or interchangeability is inferred from U.S. documents.
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 RYBELSUS be exchanged milligram for milligram with any Ozempic or Wegovy product?
No. This page only distinguishes product identity; a shared generic name, similar numbers or package photo is insufficient to establish dosage form, formulation, route or conversion. Have a pharmacist or prescribing team review the exact pack and complete medicine list.
What do 3 mg, 7 mg, 14 mg or R2 formulation numbers mean?
They are identity information on the exact product pack. The current label also notes that formulations and strengths are not self-substitutable milligram for milligram; this page does not turn these numbers into anyone's tablet-count, adjustment or conversion plan.
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.