What this pack is
CREXONT is the brand name in this record; carbidopa and levodopa extended-release capsules is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
CREXONTGeneric namecarbidopa and levodopa extended-release capsules
How this medicine works
Levodopa reaches the brain and is converted to dopamine; carbidopa mainly reduces peripheral levodopa breakdown. CREXONT uses its own immediate- and extended-release components to create a specific release profile. This explains its two ingredients and extended-release identity but cannot establish equivalence with RYTARY or another formulation or generate an individual conversion or capsule count.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More 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
- CREXONT
- Generic name
- carbidopa and levodopa extended-release capsules
- Dosage-form class
- Carbidopa/levodopa fixed two-ingredient extended-release oral capsules: 35/140, 52.5/210, 70/280 and 87.5/350 mg. Each pair states the two ingredients in one capsule. CREXONT, RYTARY, SINEMET and STALEVO are distinct products, and label numbers are not an individual conversion table.
- 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.
8 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 (SPL v19, updated 29 May 2026; verified 29 Aug 2026)
Carbidopa 35 mg plus levodopa 140 mg per capsule; carton containing a 120-capsule bottle
- Product code
- NDC 64896-967-16
- Form and route
- CREXONT carbidopa/levodopa extended-release oral capsule · oral (fixed two-ingredient extended-release product-identity field)
- Container
- bottle in carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- carbidopa
- 35 mglabelled amount of the first ingredient per capsule; not an individual dose or conversion
- levodopa
- 140 mglabelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation
- Package
- 120 capsules per bottle
- Labelled appearance
- white body and yellow cap · two-piece extended-release capsule; form does not imply permission to halve, chew or crush · imprint IPX203 / 140Capsule; tablet score status does not apply
United States label · Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)
Carbidopa 35 mg plus levodopa 140 mg per capsule; carton containing a 120-capsule bottle
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
- NDC 64896-967-23
- Form and route
- CREXONT carbidopa/levodopa extended-release oral capsule · oral (fixed two-ingredient extended-release product-identity field)
- Container
- bottle in carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- carbidopa
- 35 mglabelled amount of the first ingredient per capsule; not an individual dose or conversion
- levodopa
- 140 mglabelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation
- Package
- 120 capsules per bottle
- Labelled appearance
- white body and yellow cap · two-piece extended-release capsule; form does not imply permission to halve, chew or crush · imprint IPX203 / 140Capsule; tablet score status does not apply
United States label · Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)
Carbidopa 52.5 mg plus levodopa 210 mg per capsule; carton containing a 120-capsule bottle
- Product code
- NDC 64896-968-16
- Form and route
- CREXONT carbidopa/levodopa extended-release oral capsule · oral (fixed two-ingredient extended-release product-identity field)
- Container
- bottle in carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- carbidopa
- 52.5 mglabelled amount of the first ingredient per capsule; not an individual dose or conversion
- levodopa
- 210 mglabelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation
- Package
- 120 capsules per bottle
- Labelled appearance
- white body and green cap · two-piece extended-release capsule; form does not imply permission to halve, chew or crush · imprint IPX203 / 210Capsule; tablet score status does not apply
United States label · Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)
Carbidopa 52.5 mg plus levodopa 210 mg per capsule; carton containing a 120-capsule bottle
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
- NDC 64896-968-23
- Form and route
- CREXONT carbidopa/levodopa extended-release oral capsule · oral (fixed two-ingredient extended-release product-identity field)
- Container
- bottle in carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- carbidopa
- 52.5 mglabelled amount of the first ingredient per capsule; not an individual dose or conversion
- levodopa
- 210 mglabelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation
- Package
- 120 capsules per bottle
- Labelled appearance
- white body and green cap · two-piece extended-release capsule; form does not imply permission to halve, chew or crush · imprint IPX203 / 210Capsule; tablet score status does not apply
United States label · Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)
Carbidopa 70 mg plus levodopa 280 mg per capsule; carton containing a 120-capsule bottle
- Product code
- NDC 64896-969-16
- Form and route
- CREXONT carbidopa/levodopa extended-release oral capsule · oral (fixed two-ingredient extended-release product-identity field)
- Container
- bottle in carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- carbidopa
- 70 mglabelled amount of the first ingredient per capsule; not an individual dose or conversion
- levodopa
- 280 mglabelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation
- Package
- 120 capsules per bottle
- Labelled appearance
- white body and purple cap · two-piece extended-release capsule; form does not imply permission to halve, chew or crush · imprint IPX203 / 280Capsule; tablet score status does not apply
United States label · Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)
Carbidopa 70 mg plus levodopa 280 mg per capsule; carton containing a 120-capsule bottle
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
- NDC 64896-969-23
- Form and route
- CREXONT carbidopa/levodopa extended-release oral capsule · oral (fixed two-ingredient extended-release product-identity field)
- Container
- bottle in carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- carbidopa
- 70 mglabelled amount of the first ingredient per capsule; not an individual dose or conversion
- levodopa
- 280 mglabelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation
- Package
- 120 capsules per bottle
- Labelled appearance
- white body and purple cap · two-piece extended-release capsule; form does not imply permission to halve, chew or crush · imprint IPX203 / 280Capsule; tablet score status does not apply
United States label · Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)
Carbidopa 87.5 mg plus levodopa 350 mg per capsule; carton containing a 120-capsule bottle
- Product code
- NDC 64896-970-16
- Form and route
- CREXONT carbidopa/levodopa extended-release oral capsule · oral (fixed two-ingredient extended-release product-identity field)
- Container
- bottle in carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- carbidopa
- 87.5 mglabelled amount of the first ingredient per capsule; not an individual dose or conversion
- levodopa
- 350 mglabelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation
- Package
- 120 capsules per bottle
- Labelled appearance
- white body and medium-orange cap · two-piece extended-release capsule; form does not imply permission to halve, chew or crush · imprint IPX203 / 350Capsule; tablet score status does not apply
United States label · Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)
Carbidopa 87.5 mg plus levodopa 350 mg per capsule; carton containing a 120-capsule bottle
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
- NDC 64896-970-23
- Form and route
- CREXONT carbidopa/levodopa extended-release oral capsule · oral (fixed two-ingredient extended-release product-identity field)
- Container
- bottle in carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- carbidopa
- 87.5 mglabelled amount of the first ingredient per capsule; not an individual dose or conversion
- levodopa
- 350 mglabelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation
- Package
- 120 capsules per bottle
- Labelled appearance
- white body and medium-orange cap · two-piece extended-release capsule; form does not imply permission to halve, chew or crush · imprint IPX203 / 350Capsule; tablet score status does not apply
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 ↗PARTIAL PACKAGE-VISUAL COVERAGE
Only four of eight package identities have exact official display panels
The current SPL provides exact 120-capsule carton panels for the four -16 NDCs. The four -23 NDCs have structured text identity only. The site does not lend an image from a same-strength -16 pack to a -23 pack.
LABEL READING · NOT A PRESCRIPTION
CREXONT label reading: extended release, applesauce administration and conversion boundaries
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.
Each paired strength states carbidopa and levodopa in one capsule, not two medicines. Opening onto applesauce is limited to the labelled swallowing-difficulty method and requires the entire contents. Any transition from SINEMET, RYTARY or another product is prescriber-managed.
- Swallow whole; do not chew, divide or crush. For swallowing difficulty, the label allows opening one complete capsule, sprinkling all contents on 1–2 tablespoons of applesauce and swallowing immediately without chewing. Do not store or take only part. Do not take with alcohol.
- Immediate-release carbidopa/levodopa is not self-substitutable 1:1. The label contains professional conversion tables and clinician-facing information describing an approximately 1:1 levodopa-component transition from RYTARY, but this is not a consumer conversion rule. Do not copy tables, calculate capsules, combine old supplies or alternate products by day.
- Use with other levodopa products has not been studied, and stopping a COMT inhibitor may alter treatment needs. Do not self-add, reduce, combine, switch or rapidly stop. Use local emergency services for high fever, marked rigidity, altered consciousness or autonomic instability after a rapid reduction or withdrawal.
- Sudden sleep, marked somnolence, dizziness, hallucinations, psychotic symptoms, intense urges or new involuntary movements require prompt contact with the treating team. Professional assessment is especially important before driving or operating machinery. Family or carers may notice changes earlier.
- The 2026 label added vitamin B6 deficiency and associated seizure warnings. Depression, confusion, cheilosis, glossitis, dermatitis, anaemia, neuropathy or seizures needs clinical assessment; use emergency care for convulsions, loss of consciousness or ongoing seizures. Do not arrange tests, take high-dose B6 or stop/switch treatment from the site.
- Nonselective MAO inhibitors, including use within the previous two weeks, form a contraindication boundary. Iron salts or iron-containing multivitamins may reduce bioavailability, and dopamine D2 antagonists including metoclopramide may reduce effectiveness. Put prescriptions, non-prescription medicines, supplements and alcohol on one list for pharmacist review.
- A high-fat, high-calorie meal may delay the levodopa peak by about two hours, and a high-protein meal may reduce absorption. Do not compensate by skipping meals, radically changing protein, rescheduling or changing capsule count; have the treating team review the usual diet and symptom record.
- The label also addresses cardiovascular events, upper gastrointestinal bleeding with prior peptic ulcer, intraocular pressure in glaucoma and pregnancy animal data. Use local urgent or emergency care for chest pain, severe breathlessness, fainting, vomiting blood or black stools, acute visual change or another serious presentation.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-29
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 · 3
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. CREXONT carbidopa/levodopa extended-release capsule label (SPL v19, updated 29 May 2026) ↗Current regulatory record · reviewed 2026-08-29
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.
- FDA · United States · Regulatory product record or label archive · 2026-08-29Current FDA Orange Book data: CREXONT, NDA 217186; all four strengths are prescription RLD products, with 87.5/350 mg also listed as the RS ↗reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Drugs@FDA official search entry: CREXONT NDA 217186 application, labels and supplemental-application records ↗reviewed 2026-08-29
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 CREXONT and other carbidopa/levodopa products2026-03-20 · On 20 Mar 2026, FDA issued a Drug Safety Communication requiring every carbidopa/levodopa product to add a warning about vitamin B6 deficiency and associated seizures; the current CREXONT label includes this warning. It cannot determine an individual's deficiency, testing or supplementation need and does not support self-stopping, switching to RYTARY, SINEMET or STALEVO, changing capsule count or altering timing. Use local emergency services for a seizure, loss of consciousness or ongoing convulsions; have the prescribing team assess other suspected symptoms using the exact product and complete medicine list.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 CREXONT (carbidopa and levodopa extended-release capsules). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
CREXONT is the brand in this record and carbidopa and levodopa extended-release capsules is the active-ingredient name. Check both with the dosage form (Carbidopa/levodopa fixed two-ingredient extended-release oral capsules: 35/140, 52.5/210, 70/280 and 87.5/350 mg. Each pair states the two ingredients in one capsule. CREXONT, RYTARY, SINEMET and STALEVO are distinct products, and label numbers are not an individual conversion table.) 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.
- DailyMed (NLM): current U.S. CREXONT carbidopa/levodopa extended-release capsule label (SPL v19, updated 29 May 2026) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA Orange Book data: CREXONT, NDA 217186; all four strengths are prescription RLD products, with 87.5/350 mg also listed as the RS ↗reviewed 2026-08-29
- FDA Drugs@FDA official search entry: CREXONT NDA 217186 application, labels and supplemental-application records ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
Two ingredients and a specific extended-release design: shared ingredients do not make the same product
- CREXONT, RYTARY, SINEMET, Sinemet CR and STALEVO differ in release design or ingredient combination. Shared carbidopa/levodopa does not make per-capsule or per-tablet milligrams automatically equivalent.
- The applesauce method preserves the entire capsule contents; it does not permit grinding pellets. Chewing, crushing, taking part or storing the mixture crosses the label boundary.
- Mechanism cannot decide when an individual should change formulation, respond to missed use, receive monitoring or use a strength. The treating team must review the exact pack, symptom record and complete medicine list.
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. CREXONT carbidopa/levodopa extended-release capsule label (SPL v19, updated 29 May 2026) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA Orange Book data: CREXONT, NDA 217186; all four strengths are prescription RLD products, with 87.5/350 mg also listed as the RS ↗reviewed 2026-08-29
- FDA Drugs@FDA official search entry: CREXONT NDA 217186 application, labels and supplemental-application records ↗reviewed 2026-08-29
- FDA: CREXONT NDA 217186 original approval record (four strengths; 7 Aug 2024) ↗reviewed 2026-08-29
- FDA: CREXONT NDA 217186/S-008 supplemental approval letter for applesauce administration in swallowing difficulty (2026) ↗reviewed 2026-08-29
- FDA: CREXONT NDA 217186/S-011 supplemental approval letter for vitamin B6 deficiency and associated seizures labelling (2026) ↗reviewed 2026-08-29
- FDA: 20 Mar 2026 Drug Safety Communication on vitamin B6 deficiency and seizures with carbidopa/levodopa products ↗reviewed 2026-08-22
SOURCE-TRACEABLE ARCHIVE
CREXONTcarbidopa and levodopa extended-release capsules
This page includes an exact current U.S. public-label package panel for CREXONT, 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
Four CREXONT extended-release capsule strengths approved
The FDA original approval record confirms NDA 217186 strengths 35/140, 52.5/210, 70/280 and 87.5/350 mg; current Orange Book data list all four as prescription RLD products.
FDA: CREXONT NDA 217186 original approval record (four strengths; 7 Aug 2024) ↗FDA issued vitamin B6 deficiency and seizure safety communication
The communication covers carbidopa/levodopa products and does not determine individual deficiency, supplementation or stopping.
FDA: 20 Mar 2026 Drug Safety Communication on vitamin B6 deficiency and seizures with carbidopa/levodopa products ↗Current DailyMed page updated
SPL v19 lists four strengths, eight structured package NDCs, four exact carton panels, the applesauce method and B6 safety information.
DailyMed (NLM): current U.S. CREXONT carbidopa/levodopa extended-release capsule label (SPL v19, updated 29 May 2026) ↗Orange Book identity reviewed
All four strengths are prescription RLD products; 87.5/350 mg is also the RS.
Current FDA Orange Book data: CREXONT, NDA 217186; all four strengths are prescription RLD products, with 87.5/350 mg also listed as the RS ↗
MARKET SCOPE
Market-record boundary
United States
Four prescription RLD products; 87.5/350 mg is also RS; current SPL lists eight package NDCsFour -16 NDCs have exact carton panels; four -23 NDCs retain text identity. Regulatory records do not establish stock, purchasing eligibility or individual interchangeability.
Mainland China and other markets
Current market record not establishedNo local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients, colours or paired numbers.
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 a CREXONT capsule be opened and half taken?
No. For swallowing difficulty it may be opened only when all contents of one complete capsule are sprinkled on 1–2 tablespoons of applesauce and swallowed immediately without chewing. Do not halve, estimate pellets, crush or store.
Can CREXONT, RYTARY and SINEMET be switched directly by levodopa milligrams?
Do not self-convert. Label transition information is a clinician-managed starting point, not a consumer calculator. Take every pack, the actual prescription and symptom record to the prescribing team.
Why do eight NDCs have only four images?
The current SPL provides exact carton panels only for the four -16 NDCs. The four -23 NDCs have structured text identity only, so the site does not reuse potentially misleading images.
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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.