What this pack is
Sinemet is the brand name in this record; carbidopa and levodopa is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
SinemetGeneric namecarbidopa and levodopa
How this medicine works
The DailyMed label explains that dopamine itself does not readily cross the blood-brain barrier, while levodopa can reach the brain and be converted to dopamine. Carbidopa mainly inhibits peripheral levodopa decarboxylation, making more levodopa available for transport to the brain. This explains the fixed combination's pharmacologic pathway; it does not predict individual effect, duration, suitability or use.
Read source: United States ↗Current regulatory record · reviewed 2026-09-05More 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
- Sinemet
- Generic name
- carbidopa and levodopa
- Dosage-form class
- Current How Supplied lists immediate-release combination oral tablets 10 mg/100 mg and 25 mg/100 mg; 25 mg/250 mg is no longer marketed
- 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.
The same 25 mg / 100 mg strength still requires the NDC and score state: this label contains both a scored and an unscored current presentation.
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.
4 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 · 2026-03-19
Per tablet: carbidopa 10 mg + levodopa 100 mg; no marketing end date in the current structured record
- Product code
- NDC 78206-166-01
- Form and route
- immediate-release oral tablet · oral
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-05; actual marketing, stock and availability are not established.
- carbidopa
- 10 mgamount per tablet
- levodopa
- 100 mgamount per tablet
- Package
- 100 tablets per bottle
- Labelled appearance
- dark dapple blue · oval tablet · imprint 647Scored in this labelled presentation
United States label · 2026-03-19
Per tablet: carbidopa 25 mg + levodopa 100 mg; no marketing end date in the current structured record
- Product code
- NDC 78206-190-01
- Form and route
- immediate-release oral tablet · oral
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-05; actual marketing, stock and availability are not established.
- carbidopa
- 25 mgamount per tablet
- levodopa
- 100 mgamount per tablet
- Package
- 100 tablets per bottle
- Labelled appearance
- yellow · oval tablet · imprint 650Unscored in this labelled presentation
United States label · 2026-03-19
Per tablet: carbidopa 25 mg + levodopa 100 mg; marketing record ended 2026-02-21
- Product code
- NDC 78206-168-01
- Form and route
- immediate-release oral tablet · oral
- Listing review
- Cited product evidence reviewed 2026-09-05; actual marketing, stock and availability are not established.
- carbidopa
- 25 mgamount per tablet
- levodopa
- 100 mgamount per tablet
- Package
- 100 tablets per bottle
- Labelled appearance
- yellow · oval tablet · imprint 650Scored in this labelled presentation
United States label · 2026-03-19
Per tablet: carbidopa 25 mg + levodopa 250 mg; marketing record ended 2021-06-02
- Product code
- NDC 78206-167-01
- Form and route
- immediate-release oral tablet · oral
- Listing review
- Cited product evidence reviewed 2026-09-05; actual marketing, stock and availability are not established.
- carbidopa
- 25 mgamount per tablet
- levodopa
- 250 mgamount per tablet
- Package
- 100 tablets per bottle
- Labelled appearance
- light dapple blue · oval tablet · imprint 654Scored 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
SINEMET label reading: 25/100 is a per-tablet two-ingredient identity, not a tablet count
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 current U.S. label revised Jul 2026 and published 24 Aug 2026 to check SINEMET, carbidopa/levodopa, immediate-release tablets, both ingredients per tablet, NDC, score state, the current How Supplied section and dated historical records. It does not provide an individual tablet count, schedule, missed-use remedy, food/iron interval, combination, switch or stopping plan.
- “10/100”, “25/100” and “25/250” state carbidopa and levodopa amounts in each tablet. Do not add the two numbers into one total strength or derive today's tablet count from package numbers.
- The same 25 mg / 100 mg strength still requires the NDC, score state and date: the current How Supplied section lists NDC 78206-190-01 (unscored), while the structured marketing record for NDC 78206-168-01 (scored) ended 21 Feb 2026. Matching brand and strength cannot erase the current-versus-historical distinction or let a webpage decide splitting.
- This archive concerns immediate-release tablets. Sinemet CR, Rytary, Crexont, Dhivy, Duopa, Vyalev and other carbidopa/levodopa products are not this same presentation; do not self-substitute, combine or alternate them by ingredient name or milligram ratio.
- The label notes that dietary changes high in protein and iron salts or iron-containing multivitamins may affect levodopa availability. This page only prompts review of diet changes, supplements and the complete medicine list with a pharmacist or prescriber; it does not generate personal meal timing or spacing.
- Older age does not mean automatically taking half. The current label reports that levodopa exposure may be higher in older adults and that greater sensitivity to adverse reactions such as hallucinations cannot be ruled out. Falls, somnolence, orthostatic effects, and cognitive or behavioural changes need professional review using the exact prescription, complete medicine list and caregiver observations.
- Do not self-make-up, double, abruptly reduce or stop, or add another antiparkinson medicine. Sudden sleep, fainting, severe mental/behavioural change, fever with marked rigidity or a seizure warrants prompt local urgent medical support.
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 · 2026-09-05
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. SINEMET public label and structured NDC data (Organon; revised Jul 2026; published 24 Aug 2026) ↗Current regulatory record · reviewed 2026-09-05
Reviewed official safety records
A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.
- FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for carbidopa/levodopa products2026-03-20 · On 2026-03-20, FDA issued a Drug Safety Communication requiring all carbidopa/levodopa products to add a warning about vitamin B6 deficiency and associated seizures; the communication explicitly lists Sinemet and Sinemet CR. It covers multiple forms and routes, but cannot determine an individual’s risk, need for testing or supplementation, or support self-stopping, form changes or dose changes. Review the exact product and current label with the prescribing team or pharmacist.FDA: 20 Mar 2026 Drug Safety Communication on vitamin B6 deficiency and seizures with carbidopa/levodopa products ↗reviewed 2026-08-22
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 Sinemet (carbidopa and levodopa). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Sinemet is the brand in this record and carbidopa and levodopa is the active-ingredient name. Check both with the dosage form (Current How Supplied lists immediate-release combination oral tablets 10 mg/100 mg and 25 mg/100 mg; 25 mg/250 mg is no longer marketed) 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 carbidopa/levodopa works: one reaches the brain while the other mainly reduces peripheral breakdown
- Levodopa reaching the brain and becoming dopamine is a mechanism description, not an answer about anyone's symptom cause, degree or duration of benefit, or tablet count.
- Carbidopa acts mainly in the periphery; it does not turn the fixed combination into two freely separable medicines. A shared ingredient name across release forms, routes or brands still needs exact-product review.
- Some dietary amino acids, iron and co-medications may affect this process, but a mechanism page cannot calculate personal meal timing, make-up use or spacing. Older people with multiple medicines should bring actual bottles, supplements and the full list for pharmacist or prescribing-team review.
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. SINEMET public label and structured NDC data (Organon; revised Jul 2026; published 24 Aug 2026) ↗Current regulatory record · reviewed 2026-09-05
- DailyMed (NLM): current U.S. SINEMET electronic label PDF (Organon; revised Jul 2026) ↗Current regulatory record · reviewed 2026-09-05
- FDA: SINEMET NDA 017555 S-076 approval letter (19 Mar 2026) ↗reviewed 2026-08-20
- FDA: 2022 clinical-pharmacology review with SINEMET 1975 approval-history context ↗Historical public record · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Sinemetcarbidopa and levodopa
This page includes an exact current U.S. public-label package panel for Sinemet, 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 year supported by later FDA reviews
A 2022 FDA clinical-pharmacology review records SINEMET approval in 1975. Another later FDA source has one conflicting May day, so this page publishes only the year.
FDA: 2022 clinical-pharmacology review with SINEMET approval-history context ↗NDA 017555 S-076 approval and label revision
The FDA public letter records S-076 approval on 19 Mar 2026; the current DailyMed label carries the same revision date.
FDA: SINEMET NDA 017555 S-076 approval letter ↗Current SPL v6 published on DailyMed
The current DailyMed record shows text revised Jul 2026 and v6 published 24 Aug 2026. The current How Supplied section lists only 10/100 NDC 78206-166-01 and 25/100 NDC 78206-190-01, while structured data retain two historical NDCs with marketing-end dates.
DailyMed: current SINEMET public label and structured NDC data ↗
MARKET SCOPE
Market-record boundary
United States
Two NDCs in current How Supplied; two dated historical NDCsThe current How Supplied section lists 78206-166-01 and 78206-190-01. Structured records show 78206-168-01 ended 21 Feb 2026 and 78206-167-01 ended 2 Jun 2021. Regulatory records do not prove live stock.
Mainland China, EU, Japan
Market record not establishedNo local trade name, approval, strength, supply or originator relationship is inferred from the U.S. archive.
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 the historical scored 25/100 pack be treated as the current pack for splitting?
No. The current How Supplied section lists unscored NDC 78206-190-01; the marketing record for scored NDC 78206-168-01 has ended. A package image, shared strength or historical score line cannot replace the exact bottle, current label and pharmacist review.
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.