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RYTARY Carbidopa and Levodopa 195 mg; 48.75 mg Capsule, Extended Release, 100-count — NDC 64896-0663-99 package photo

RYTARY Carbidopa and Levodopa 195 mg; 48.75 mg Capsule, Extended Release, 100-count

by Amneal Pharmaceuticals LLC · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-99)
NDC 64896-0663-99
🏷️ FDA NDC (as labeled) 64896-663-99 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $3.99/unit — full pricing hub ↓
Also comes in: 25 capsules 64896-0663-09 100 capsules 64896-0663-01 240 capsules 64896-0663-43
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 64896-663-99
Product NDC 64896-663
11-digit billing NDC 64896066399
RxCUI 1600773, 1600774, 1600775, 1600776, 1600914, 1600915, 1600916, 1600917
UNII 46627O600J, MNX7R8C5VO
UPC 0364896663016, 0364896664013, 0364896662019, 0364896661012
Application # NDA203312
SPL Set ID 6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7
Established class (EPC) Aromatic Amino Acid
Chemical class Amino Acids, Aromatic
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-01-12
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance LEVODOPA; CARBIDOPA HYDRATE
GPI-14 73209902100240
GPI class Rytary
GCN Seq No 073310
GCN 37695
HICL code 013894
Ingredient (HICL) Carbidopa/Levodopa
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6A
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Other
AHFS code 28:36.16.00
AHFS class Dopamine Precursors
FDB label name RYTARY ER 48.75 MG-195 MG CAP
FDB brand name Rytary
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 64896-663-99 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 64896-0663-99. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Aromatic Amino Acid Decarboxylation Inhibitor class.

Pharmacologic class Aromatic Amino Acid Decarboxylation Inhibitor
How it works DOPA Decarboxylase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC
Application holderIMPAX LABORATORIES LLC
FDA applicationNDA203312 (NDA)
Labeler code64896
First marketedJan 2015
Product typeHuman Prescription Drug
Portfolio467 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name RYTARY ER 48.75 MG-195 MG CAP Ingredient Carbidopa/Levodopa
📖 What it is MedlinePlus · NLM

Levodopa and carbidopa is used to treat the symptoms of Parkinson's disease and Parkinson's-like symptoms that may develop after encephalitis (swelling of the brain) or injury to the nervous system caused by carbon monoxide poisoning or manganese poisoning. Levodopa is in a class of medications called central nervous system agents. It works by being converted to dopamine in the brain (the natural substance that is low in Parkinson's and causes the symptoms of tremor, stiffness, and slowness of movement). Carbidopa is in a class of medications called decarboxylase inhibitors. It works by preven...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Levodopa is the medicine that actually works in your brain — it crosses into the brain and gets converted into dopamine, the chemical that Parkinson's disease depletes. The problem...
  • What exactly does levodopa and carbidopa do, and why do I need both?
  • Generally yes, but the timing and content of your meals can matter. High-protein foods — like large servings of meat, eggs, or dairy — can compete with levodopa for absorption in y...
  • Can I eat normally while taking this medication?
📖 Read our full Levodopa and Carbidopa guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color blue / white / yellow
ShapeCapsule
ImprintIPX066;245
Size23 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 74G4R6TH13
    A synthetic polymer made by combining two plastic-like chemicals. It forms a coating on tablets or capsules that dissolves at a specific point in the digestive tract, controlling where and when the medicine releases.
  • UNII 5KY68S2577
    A synthetic plastic polymer made from two chemical compounds combined in a specific ratio. It forms a coating on tablets and capsules to control how and where the medication dissolves in the digestive tract.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

24 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $3.99 $398.83 / 100 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Carbidopa and Levodopa 48.75 mg/1; 195 mg 70710-2141-01 Zydus 100 capsules $3.126 — Availability likely —
Rytary 195 mg/1; 48.75 mgthis 64896-0663-99 Amneal 100 capsules — — FDA listed —
Carbidopa and Levodopa 48.75 mg/1; 195 mg 70518-4621-00 REMEDYREPACK 1 capsule — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
First FDA approval
Jan 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 7, 2015 RLD RS ⏳ ~2.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9089607 — method of use (U-1645)
US 9089607 — method of use (U-1720)
US 9089607 — method of use (U-1645)
US 8377474 — method of use (U-219)
US 8377474 — method of use (U-1645)
US 8377474 — method of use (U-219)
US 8377474 — method of use (U-219)
US 8377474 — method of use (U-1645)
US 8454998 — method of use (U-1645)
US 8454998 — method of use (U-1649)
US 8454998 — method of use (U-1646)
US 8454998 — method of use (U-1649)
US 8454998 — method of use (U-219)
US 8454998 — method of use (U-1647)
US 8454998 — method of use (U-1645)
US 8454998 — method of use (U-1647)
US 8454998 — method of use (U-1649)
US 8454998 — method of use (U-219)
US 8454998 — method of use (U-1646)
US 8454998 — method of use (U-219)
US 8454998 — method of use (U-1645)
US 8557283 — method of use (U-219)
US 8557283 — method of use (U-1645)
US 9901640 — method of use (U-219)
US 9089607 — method of use (U-1645)
US 9089607 — method of use (U-1645)
US 9089607 — method of use (U-1720)
US 9533046 — method of use (U-219)
US 9463246 — method of use (U-219)
US 9463246 — method of use (U-219)
US 8557283 — method of use (U-219)
US 8557283 — method of use (U-1645)
US 9901640 — method of use (U-219)
US 9089607 — method of use (U-1720)
US 9089607 — method of use (U-1720)
US 8454998 — method of use (U-1647)
US 8454998 — method of use (U-1645)
US 8454998 — method of use (U-1646)
US 8377474 — method of use (U-1645)
US 8557283 — method of use (U-1645)
US 8454998 — method of use (U-1646)
US 8377474 — method of use (U-219)
US 8454998 — method of use (U-1649)
US 8557283 — method of use (U-219)
US 9463246 — method of use (U-219)
US 9901640 — method of use (U-219)
US 9901640 — method of use (U-219)
US 9533046 — method of use (U-219)
US 8557283 — method of use (U-1645)
US 8454998 — method of use (U-219)
US 8557283 — method of use (U-219)
US 8377474 — method of use (U-1645)
US 8454998 — method of use (U-1647)
US 9533046 — method of use (U-219)
US 9533046 — method of use (U-219)
US 9463246 — method of use (U-219)
US 9089608 — drug product
US 9089608 — drug product
US 9089608 — drug product
US 9089608 — drug product
2015 2017 2019 2021 2023 2025 2027 2029
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (60)
PatentTypeUse codeExpires
US 9089607 ↗ Method of use U-1645 Dec 26, 2028
US 9089607 ↗ Method of use U-1720 Dec 26, 2028
US 9089607 ↗ Method of use U-1645 Dec 26, 2028
US 8377474 ↗ Method of use U-219 Dec 26, 2028
US 8377474 ↗ Method of use U-1645 Dec 26, 2028
US 8377474 ↗ Method of use U-219 Dec 26, 2028
US 8377474 ↗ Method of use U-219 Dec 26, 2028
US 8377474 ↗ Method of use U-1645 Dec 26, 2028
US 8454998 ↗ Method of use U-1645 Dec 26, 2028
US 8454998 ↗ Method of use U-1649 Dec 26, 2028
US 8454998 ↗ Method of use U-1646 Dec 26, 2028
US 8454998 ↗ Method of use U-1649 Dec 26, 2028
US 8454998 ↗ Method of use U-219 Dec 26, 2028
US 8454998 ↗ Method of use U-1647 Dec 26, 2028
US 8454998 ↗ Method of use U-1645 Dec 26, 2028
US 8454998 ↗ Method of use U-1647 Dec 26, 2028
US 8454998 ↗ Method of use U-1649 Dec 26, 2028
US 8454998 ↗ Method of use U-219 Dec 26, 2028
US 8454998 ↗ Method of use U-1646 Dec 26, 2028
US 8454998 ↗ Method of use U-219 Dec 26, 2028
US 8454998 ↗ Method of use U-1645 Dec 26, 2028
US 8557283 ↗ Method of use U-219 Dec 26, 2028
US 8557283 ↗ Method of use U-1645 Dec 26, 2028
US 9901640 ↗ Method of use U-219 Dec 26, 2028
US 9089607 ↗ Method of use U-1645 Dec 26, 2028
US 9089607 ↗ Method of use U-1645 Dec 26, 2028
US 9089607 ↗ Method of use U-1720 Dec 26, 2028
US 9533046 ↗ Method of use U-219 Dec 26, 2028
US 9463246 ↗ Method of use U-219 Dec 26, 2028
US 9463246 ↗ Method of use U-219 Dec 26, 2028
US 8557283 ↗ Method of use U-219 Dec 26, 2028
US 8557283 ↗ Method of use U-1645 Dec 26, 2028
US 9901640 ↗ Method of use U-219 Dec 26, 2028
US 9089607 ↗ Method of use U-1720 Dec 26, 2028
US 9089607 ↗ Method of use U-1720 Dec 26, 2028
US 8454998 ↗ Method of use U-1647 Dec 26, 2028
US 8454998 ↗ Method of use U-1645 Dec 26, 2028
US 8454998 ↗ Method of use U-1646 Dec 26, 2028
US 8377474 ↗ Method of use U-1645 Dec 26, 2028
US 8557283 ↗ Method of use U-1645 Dec 26, 2028
US 8454998 ↗ Method of use U-1646 Dec 26, 2028
US 8377474 ↗ Method of use U-219 Dec 26, 2028
US 8454998 ↗ Method of use U-1649 Dec 26, 2028
US 8557283 ↗ Method of use U-219 Dec 26, 2028
US 9463246 ↗ Method of use U-219 Dec 26, 2028
US 9901640 ↗ Method of use U-219 Dec 26, 2028
US 9901640 ↗ Method of use U-219 Dec 26, 2028
US 9533046 ↗ Method of use U-219 Dec 26, 2028
US 8557283 ↗ Method of use U-1645 Dec 26, 2028
US 8454998 ↗ Method of use U-219 Dec 26, 2028
US 8557283 ↗ Method of use U-219 Dec 26, 2028
US 8377474 ↗ Method of use U-1645 Dec 26, 2028
US 8454998 ↗ Method of use U-1647 Dec 26, 2028
US 9533046 ↗ Method of use U-219 Dec 26, 2028
US 9533046 ↗ Method of use U-219 Dec 26, 2028
US 9463246 ↗ Method of use U-219 Dec 26, 2028
US 9089608 ↗ Drug product — Dec 26, 2028
US 9089608 ↗ Drug product — Dec 26, 2028
US 9089608 ↗ Drug product — Dec 26, 2028
US 9089608 ↗ Drug product — Dec 26, 2028
Common questions
Is there a generic version of RYTARY ER 48.75 MG-195 MG CAP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for RYTARY ER 48.75 MG-195 MG CAP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2028 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules64896-0663-01 1,172 Rx · $1,054,822
25 capsules64896-0663-09 No Medicaid data
240 capsules64896-0663-43 No Medicaid data
100 capsules this page64896-0663-99 No Medicaid data
Drug total (last 4 qtrs): 1,172 Rx · 263,079 units · $1,054,822 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Rytary — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Rytary. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$41.41M
Claims incl. refills
37.1K
Beneficiaries
18.3K
Spend / beneficiary
$2,261.68
Spend / claim
$1,116.63
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Carbidopa and Levodopa — the ingredient across all brands.

Top reported reactions

Fall4,472
Hallucination3,935
Tremor3,311
Dyskinesia3,020
Death2,907
Parkinson^s Disease2,539
Dizziness2,523

Age at onset

Neonate1
Infant1
Child12
Adolescent3
Adult553
Elderly1,778

Reporter sex

47,176 reports
Male · 57%
Female · 43%
Unknown · 0%

Serious outcomes

Hospitalization13,018
Death5,934
Disabling759
Life-threatening713
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,898 1,379
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
64896-0663-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-01) $3.98 / ea $398.30 2015-01-12 Active
64896-0663-09 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-09) — — 2015-01-12 Active
64896-0663-43 240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-43) — — 2015-01-12 Active
64896-0663-99 You're viewing this 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-99) — — 2015-01-12 Active

This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 64896-0663-99?
NDC 64896-0663-99 is a 100-count package — 100 capsule, extended release in 1 bottle.
What is the difference between NDC 64896-0663-99 and NDC 64896-0663-09?
Both are RYTARY Carbidopa and Levodopa 195 mg; 48.75 mg Capsule, Extended Release — the drug itself is identical. NDC 64896-0663-99 is the 100-count package, while NDC 64896-0663-09 is the 25 capsules package.
What NDC number is used to bill for this package of RYTARY Carbidopa and Levodopa 195 mg; 48.75 mg Capsule, Extended Release?
Bill NDC 64896-0663-99 — the 11-digit billing format is 64896066399. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 64896-663-99, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 64896-0663-99, written without dashes as 64896066399. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 64896-0663-99, the first segment (64896) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0663) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (99) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 25 capsules (64896-0663-09), 100 capsules (64896-0663-01), 240 capsules (64896-0663-43). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Amneal Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 67 words ▾

1 INDICATIONS AND USAGE RYTARY is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. RYTARY is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) Levodopa-naïve patients: Starting dose is 23.75 mg/95 mg three times daily; may increase to 36.25 mg/145 mg three times daily on the fourth day of treatment. ( 2.2 ) See Table 1 for instructions for converting patients taking immediate-release carbidopa-levodopa to an initial dose of RYTARY.

Dosages of RYTARY are not interchangeable with other carbidopa-levodopa products. ( 2.3 ) The maximum recommended daily dose of RYTARY is 612.5 mg/2,450 mg. ( 2.2 , 2.3 ) RYTARY may be taken with or without food; do not chew, divide or crush.

( 2.5 , 12.3 )

2.1Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating carbidopa/levodopa therapies, including RYTARY, periodically during treatment, and as clinically indicated [see Warnings and Precautions (5.7) ]. If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with RYTARY while supplementing vitamin B6.

2.2Dosage in Patients Naïve to Levodopa Therapy The recommended starting dosage of RYTARY in levodopa-naïve patients is 23.75 mg/95 mg taken orally three times a day for the first 3 days. On the fourth day of treatment, the dosage of RYTARY may be increased to 36.25 mg/145 mg taken three times a day. Based upon individual patient clinical response and tolerability, the RYTARY dose may be increased up to a maximum recommended dose of 97.5 mg/390 mg taken three times a day.

The dosing frequency may be changed from three times a day to a maximum of five times a day if more frequent dosing is needed and if tolerated. Maintain patients on the lowest dosage required to achieve symptomatic control and to minimize adverse reactions such as dyskinesia and nausea. The maximum recommended daily dose of RYTARY is 612.5 mg/2,450 mg.

2.3Converting from Immediate-Release Carbidopa-Levodopa to RYTARY The dosages of other carbidopa and levodopa products are not interchangeable on a 1:1 basis with the dosages of RYTARY. To convert patients from immediate-release carbidopa-levodopa to RYTARY, first calculate the patient’s current total daily dose of levodopa. The starting total daily dose of RYTARY is as recommended in Table 1.

After conversion, any combination of the four RYTARY dosage strengths can be used to achieve an optimal dosing. Adjust the dose and dosing frequency as necessary to maintain patient tolerance and sufficient symptomatic control. Administration of concomitant Parkinson’s disease medications should remain stable while adjusting the RYTARY dose.

In clinical trials, RYTARY was administered in divided doses of three to five times a day. The maximum recommended total daily dose of RYTARY is 612.5 mg/2,450 mg. For patients currently treated with carbidopa and levodopa plus a catechol-O-methyl transferase (COMT) inhibitor (such as entacapone), the initial total daily dose of levodopa in RYTARY described in Table 1 may need to be increased.

Use of RYTARY in combination with other levodopa products has not been studied. Table 1 : Conversion from Immediate-Release Carbidopa-Levodopa to RYTARY Total Daily Dose of Levodopa in Immediate-Release Carbidopa-Levodopa Recommended Starting Dosage of RYTARY Total Daily Dose of Levodopa in RYTARY RYTARY Dosing Regimen 400 mg to 549 mg 855 mg 3 capsules RYTARY 23.75 mg/95 mg taken TID a 550 mg to 749 mg 1,140 mg 4 capsules RYTARY 23.75 mg/95 mg taken TID 750 mg to 949 mg 1,305 mg 3 capsules RYTARY 36.25 mg/145 mg taken TID 950 mg to 1,249 mg 1,755 mg 3 capsules RYTARY 48.75 mg/195 mg taken TID Equal to or greater than 1,250 mg 2,340 mg or 4 capsules RYTARY 48.75 mg/195 mg taken TID or 2,205 mg 3 capsules RYTARY 61.25 mg/245 mg taken TID a TID: three times a day

2.4Discontinuation of RYTARY Avoid sudden discontinuation or rapid dose reduction of RYTARY. The daily dose of RYTARY should be tapered at the time of treatment discontinuation…

💊 Dosage Forms and Strengths 122 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release capsules: 23.75 mg carbidopa and 95 mg levodopa: blue and white capsule imprinted with IPX066 on the capsule cap and 95 on the capsule body. 36.25 mg carbidopa and 145 mg levodopa: blue and light blue capsule imprinted with IPX066 on the capsule cap and 145 on the capsule body. 48.75 mg carbidopa and 195 mg levodopa: blue and yellow capsule imprinted with IPX066 on the capsule cap and 195 on the capsule body.

61.25mg carbidopa and 245 mg levodopa: blue capsule imprinted with IPX066 on the capsule cap and 245 on the capsule body. Extended-release capsules: Carbidopa and levodopa 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, 61.25 mg/245 mg. ( 3 )

⛔ Contraindications 51 words ▾

4 CONTRAINDICATIONS RYTARY is contraindicated in patients: Currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions (7.1) ] . Nonselective MAO inhibitors. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS May cause falling asleep during activities of daily living. ( 5.1 ) Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion. ( 5.2 ) Cardiovascular Events: Monitor patients with a history of cardiovascular disease.

( 5.3 ) Hallucinations/Psychosis may occur. ( 5.4 ) Impulse Control Disorders: Consider dose reduction or stopping RYTARY if occurs. ( 5.5 ) May cause or exacerbate dyskinesia: Consider dose reduction.

( 5.6 )

5.1Falling Asleep During Activities of Daily Living and Somnolence Patients treated with levodopa, a component of RYTARY, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events have been reported more than 1 year after initiation of treatment.

It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of pre-existing somnolence, although patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness in RYTARY-treated patients, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Before initiating treatment with RYTARY, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with RYTARY such as concomitant sedating medications or the presence of a sleep disorder. Consider discontinuing RYTARY in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.). If a decision is made to continue RYTARY, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent.

There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

5.2Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction in patients taking RYTARY. If the decision is made to discontinue RYTARY, the dose should be tapered to reduce the risk of hyperpyrexia and confusion [see Dosage and Administration (2.4) ] .

5.3Cardiovascular Ischemic Events Cardiovascular ischemic events have occurred in patients taking RYTARY. In a placebo controlled clinical study in patients with early Parkinson's disease, 7/289 (2.4%) of RYTARY-treated patients experienced cardiovascular ischemic adverse reactions compared to 1/92 (1.1%) of placebo-treated patients. In an active-controlled clinical study in patients with advanced Parkinson's disease, 3/450 (0.7%) of RYTARY-treated patients experienced cardiovascular ischemic adverse reactions compared to 0/471 oral immediate-release carbidopa-levodopa-treated patients.

These patients all had a previous history of ischemic heart disease or risk factors for ischemic heart disease. In patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias, cardiac function should be monitored in an intensive cardiac care facility during the p…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.2) ] Cardiovascular Ischemic Events [see Warnings and Precautions (5.3) ] Hallucinations/Psychosis [see Warnings and Precautions (5.4) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.5) ] Dyskinesia [see Warnings and Precautions (5.6) ] Vitamin B6 Deficiency and Seizures [see Warnings and Precautions (5.7) ] Peptic Ulcer Disease [see Warnings and Precautions (5.8) ] Glaucoma [see Warnings and Precautions (5.9) ] Early Parkinson's disease: Most common adverse reactions (incidence ≥ 5% and greater than placebo) are nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.

( 6.1 ) Advanced Parkinson's disease: Most common adverse reactions (incidence ≥ 5% and greater than oral immediate-release carbidopa-levodopa) are nausea and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety population consisted of a total of 978 Parkinson’s disease patients who received at least one dose of RYTARY, and had an average duration of exposure of 40 weeks. Adverse Reactions in Early Parkinson’s Disease In a placebo-controlled clinical study in patients with early Parkinson’s disease (Study 1), the most common adverse reactions with RYTARY (in at least 5% of patients and more frequently than in placebo) were nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.

Table 2 lists adverse reactions occurring in at least 5% of RYTARY-treated patients and at a higher rate than placebo in Study 1. Table 2: Adverse Reactions in Study 1 in Patients with Early Stage Parkinson’s Disease Placebo RYTARY 36.25 mg Carbidopa 145 mg Levodopa TID RYTARY 61.25 mg Carbidopa 245 mg Levodopa TID RYTARY 97.5 mg Carbidopa 390 mg Levodopa TID (N=92) % (N=87) % (N=104) % (N=98) % Nausea 9 14 19 20 Dizziness 5 9 19 12 Headache 11 7 13 17 Insomnia 3 2 9 6 Abnormal Dreams 0 2 6 5 Dry Mouth 1 3 2 7 Dyskinesia 0 2 4 5 Anxiety 0 2 3 5 Constipation 1 2 6 2 Vomiting 3 2 2 5 Orthostatic Hypotension 1 1 1 5 Adverse Reactions Leading to Discontinuation in Study 1 In Study 1, 12% of patients discontinued RYTARY early due to adverse reactions; a higher proportion of patients in the 61.25 mg/245 mg RYTARY-treated group (14%) and in the 97.5 mg/390 mg RYTARY-treated group (15%) experienced adverse reactions leading to early discontinuation compared to (4%) in the placebo group.

The most common adverse reactions resulting in early discontinuation were nausea, dizziness, and vomiting. Adverse Reactions in Advanced Parkinson’s Disease In an active-controlled clinical study in patients with advanced Parkinson’s disease (Study 2), the most common adverse reactions with RYTARY that occurred during dose conversion or maintenance (in at least 5% of patients and more frequently than on oral immediate-release carbidopa-levodopa) were nausea and headache. Table 3 lists adverse reactions occurring in at least 5% of RYTARY-treated patients and at a higher rate than oral immediate-release carbidopa-levodopa in Study 2.

Table 3: Adverse Reactions in Study 2 in Patients with Advanced Parkinson’s Disease RYTARY (N=201) Immediate-Release Carbidopa-Levodopa (N=192) Period Dose Conversion a % Maintenance % Dose Conve…

🔄 Drug Interactions 158 words ▾

7 DRUG INTERACTIONS Iron salts and dopamine D2 antagonists including metoclopramide: May reduce the effectiveness of RYTARY. ( 7.2 , 7.3 )

7.1Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with RYTARY is contraindicated [see Contraindications (4) ] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating RYTARY. The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with RYTARY may be associated with orthostatic hypotension. Monitor patients who are taking these drugs concurrently.

7.2Dopamine D2 Receptor Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Monitor patients for worsening Parkinson's symptoms.

7.3Iron Salts Iron salts or multivitamins containing iron salts can form chelates with levodopa and carbidopa and can cause a reduction in the bioavailability of RYTARY. If iron salts or multivitamins containing iron salts are co-administered with RYTARY, monitor patients for worsening Parkinson's symptoms.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of RYTARY in pregnant women. In animal studies, carbidopa-levodopa has been shown to be developmentally toxic (including teratogenic effects) at clinically relevant doses (see Data) . The estimated background risk of major birth defects and miscarriage in the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data When administered to pregnant rabbits throughout organogenesis, carbidopa-levodopa caused both visceral and skeletal malformation in fetuses at all doses and ratios of carbidopa-levodopa tested. No teratogenic effects were observed when carbidopa-levodopa was administered to pregnant mice throughout organogenesis.

There was a decrease in the number of live pups delivered by rats receiving carbidopa-levodopa during organogenesis.

8.2Lactation Risk Summary Levodopa has been detected in human milk after administration of carbidopa-levodopa. There are no data on the presence of carbidopa in human milk, the effects of levodopa or carbidopa on the breastfed infant, or the effects on milk production. However, inhibition of lactation may occur because levodopa decreases secretion of prolactin in humans.

Carbidopa is excreted in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RYTARY and any potential adverse effects on the breastfed infant from RYTARY or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use In controlled clinical trials of RYTARY, 418 patients were 65 years or older and no overall differences in safety and efficacy were observed between these patients and those under 65 years of age.

🤰 Pregnancy 145 words ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of RYTARY in pregnant women. In animal studies, carbidopa-levodopa has been shown to be developmentally toxic (including teratogenic effects) at clinically relevant doses (see Data) . The estimated background risk of major birth defects and miscarriage in the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data When administered to pregnant rabbits throughout organogenesis, carbidopa-levodopa caused both visceral and skeletal malformation in fetuses at all doses and ratios of carbidopa-levodopa tested. No teratogenic effects were observed when carbidopa-levodopa was administered to pregnant mice throughout organogenesis.

There was a decrease in the number of live pups delivered by rats receiving carbidopa-levodopa during organogenesis.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 36 words ▾

8.5Geriatric Use In controlled clinical trials of RYTARY, 418 patients were 65 years or older and no overall differences in safety and efficacy were observed between these patients and those under 65 years of age.

🆘 Overdosage 168 words ▾

10 OVERDOSAGE In the active-controlled clinical study, a patient accidentally ingested 4.68 grams of carbidopa/18.7 grams of levodopa contained in RYTARY over a 2-day period. The patient experienced acute psychosis and dyskinesias. The patient recovered and completed the study on a reduced dose of RYTARY.

Based on the limited available information, the acute symptoms of levodopa/dopa decarboxylase inhibitor overdosage can be expected to arise from dopaminergic overstimulation. Doses of a few grams may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g., hypotension, tachycardia) and more severe psychiatric problems at higher doses. An isolated report of rhabdomyolysis and another of transient renal insufficiency suggest that levodopa overdosage may give rise to systemic complications, secondary to dopaminergic overstimulation.

Monitor patients and provide supportive care. Patients should receive electrocardiographic monitoring for the development of arrhythmias; if needed, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs, increasing the risk of drug interactions (especially catechol-structured drugs) should be taken into consideration.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Carbidopa When levodopa is administered orally, it is rapidly decarboxylated to dopamine in extracerebral tissues so that only a small portion of a given dose is transported unchanged to the central nervous system. Carbidopa inhibits the decarboxylation of peripheral levodopa, making more levodopa available for delivery to the brain. Levodopa Levodopa is the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain.

This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson's disease.

12.2Pharmacodynamics Because its decarboxylase inhibiting activity is limited to extracerebral tissues, administration of carbidopa with levodopa makes more levodopa available to the brain. The addition of carbidopa to levodopa reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa. Patients treated with levodopa therapy for Parkinson's disease may develop motor fluctuations characterized by end-of-dose failure, peak dose dyskinesia, ‘on-off’ phenomenon, and akinesia.

12.3Pharmacokinetics Absorption Carbidopa Following oral dosing of RYTARY the maximum concentration occurred at approximately 3 hours. The bioavailability of carbidopa from RYTARY relative to immediate-release carbidopa-levodopa tablets was approximately 50%. Levodopa The pharmacokinetics of RYTARY were evaluated following single-doses in healthy subjects and following single- and multiple-doses in patients with Parkinson’s disease.

The bioavailability of levodopa from RYTARY in patients was approximately 70% relative to immediate-release carbidopa-levodopa. For comparable doses, RYTARY results in a levodopa peak concentration (C max ) that is 30% that of immediate-release carbidopa-levodopa. Following an initial peak at about one hour, plasma concentrations are maintained for about 4 to 5 hours before declining.

In patients with Parkinson’s disease, multiple-dose pharmacokinetics was comparable to single-dose pharmacokinetics, i.e., there was minimal accumulation of levodopa. Variation in levodopa peak to trough plasma concentrations at steady-state defined as (C max -C min )/C avg was approximately 1.5 for RYTARY compared to approximately 3.2 for immediate-release levodopa. Distribution Carbidopa is approximately 36% bound to plasma proteins.

Approximately 10% to 30% of levodopa is bound to plasma protein. Metabolism and Elimination Carbidopa The terminal phase elimination half-life of carbidopa is approximately 2 hours. Carbidopa is metabolized to two main metabolites: α-methyl-3-methoxy-4-hydroxyphenylpropionic acid and α-methyl-3,4-dihydroxy-phenylpropionic acid.

These two metabolites are primarily eliminated in the urine unchanged or as a glucuronide. Unchanged carbidopa accounts for 30% of the total urinary excretion. Peripheral dopa-decarboxylase may be saturated by carbidopa in other carbidopa-levodopa products at 70 mg per day to 100 mg per day, which produces equivalent exposure to 140 mg to 200 mg of carbidopa provided by RYTARY.

Levodopa The terminal phase elimination half-life of levodopa, the active moiety of antiparkinsonian activity, is approximately 2 hours in the presence of carbidopa. Levodopa is extensively metabolized to various metabolites. The two major metabolic pathways are decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase (COMT).

Dose Proportionality RYTARY shows approximately dose proportional pharmacokinetics for both carbidopa and levodopa over the levodopa dosage strength range of 95 mg to 245 mg. Effect of Food In healthy adults, oral administration of RYTARY after a high-fat, high-calorie meal reduced C max approximately 21% and increased AUC inf approximately 13% for levodopa compared to administration in the fasted state. There may be a del…

🧬 Mechanism of Action 89 words ▾

12.1Mechanism of Action Carbidopa When levodopa is administered orally, it is rapidly decarboxylated to dopamine in extracerebral tissues so that only a small portion of a given dose is transported unchanged to the central nervous system. Carbidopa inhibits the decarboxylation of peripheral levodopa, making more levodopa available for delivery to the brain. Levodopa Levodopa is the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain.

This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson's disease.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied RYTARY (carbidopa and levodopa) Extended-Release Capsules are available in the following strengths: 23.75 mg Carbidopa and 95 mg of Levodopa: blue and white capsule imprinted with IPX066 on the capsule cap and 95 on the capsule body. They are available as follows: Bottles of 100: (NDC 64896-661-01) Bottles of 240: (NDC 64896-661-43) 36.25 mg Carbidopa and 145 mg Levodopa: blue and light blue capsule imprinted with IPX066 on the capsule cap and 145 on the capsule body. They are available as follows: Bottles of 100: (NDC 64896-662-01) Bottles of 240: (NDC 64896-662-43) 48.75 mg Carbidopa and 195 mg Levodopa: blue and yellow capsule imprinted with IPX066 on the capsule cap and 195 on the capsule body.

They are available as follows: Bottles of 100: (NDC 64896-663-01) Bottles of 240: (NDC 64896-663-43) 61.25 mg Carbidopa and 245 mg Levodopa: blue capsule imprinted with IPX066 on the capsule cap and 245 on the capsule body. They are available as follows: Bottles of 100: (NDC 64896-664-01) Bottles of 240: (NDC 64896-664-43)

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture. Dispense in a tightly closed, light-resistant container.

16.1How Supplied RYTARY (carbidopa and levodopa) Extended-Release Capsules are available in the following strengths: 23.75 mg Carbidopa and 95 mg of Levodopa: blue and white capsule imprinted with IPX066 on the capsule cap and 95 on the capsule body. They are available as follows: Bottles of 100: (NDC 64896-661-01) Bottles of 240: (NDC 64896-661-43) 36.25 mg Carbidopa and 145 mg Levodopa: blue and light blue capsule imprinted with IPX066 on the capsule cap and 145 on the capsule body. They are available as follows: Bottles of 100: (NDC 64896-662-01) Bottles of 240: (NDC 64896-662-43) 48.75 mg Carbidopa and 195 mg Levodopa: blue and yellow capsule imprinted with IPX066 on the capsule cap and 195 on the capsule body.

They are available as follows: Bottles of 100: (NDC 64896-663-01) Bottles of 240: (NDC 64896-663-43) 61.25 mg Carbidopa and 245 mg Levodopa: blue capsule imprinted with IPX066 on the capsule cap and 245 on the capsule body. They are available as follows: Bottles of 100: (NDC 64896-664-01) Bottles of 240: (NDC 64896-664-43)

📦 Storage and Handling 44 words ▾

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture. Dispense in a tightly closed, light-resistant container.

📋 Description ~1 min read ▾

11 DESCRIPTION RYTARY is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate.

Its molecular formula is C 10 H 14 N 2 O 4 • H 2 O and its structural formula is: Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine.

Its molecular formula is C 9 H 11 NO 4 and its structural formula is: Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate.

All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide.

All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution. 1 2

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Dosing Instructions Advise patients to not take other carbidopa-levodopa preparations with RYTARY without consulting their healthcare provider [see Dosage and Administration (2.3) ] . Advise patients to call their healthcare provider before stopping RYTARY. Discontinue RYTARY slowly.

Tell patients to call their healthcare provider if they develop withdrawal symptoms such as fever, confusion or severe muscle stiffness [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ]. Advise patients to swallow RYTARY capsules whole, without chewing, dividing, or crushing [see Dosage and Administration (2.5) ] . For patients with difficulty swallowing, the entire contents of the RYTARY capsule may be sprinkled on 1 to 2 tablespoons of applesauce and should be taken immediately [see Dosage and Administration (2.5) ] .

Inform patients that a high fat, high calorie meal may delay the absorption of levodopa and the onset of action by 2 to 3 hours. For this reason, consideration should be given to taking the first dose of the day about 1 to 2 hours before eating [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . Falling Asleep Advise patients that certain side effects such as sleepiness and dizziness that have been reported with RYTARY may affect some patients’ ability to drive and operate machinery safely [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .

Suicide Attempt and Suicidal Ideation Instruct patients, family members and caregivers to notify their healthcare provider if suicide attempt and/or suicidal ideation are experienced by patients using RYTARY [see Adverse Reactions (6.2) ] . Hallucinations and Psychosis Inform patients that hallucinations can occur with levodopa products [see Warnings and Precautions (5.4) ] . Impulse Control Disorder Inform patients of the potential for experiencing intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson’s disease [see Warnings and Precautions (5.5) ] .

Dyskinesia Instruct patients to notify their healthcare provider if abnormal involuntary movements appear or get worse during treatment with RYTARY [see Warnings and Precautions (5.6 )] . Vitamin B6 Deficiency and Seizures Inform patients that vitamin B6 deficiency may develop during treatment with carbidopa/levodopa therapies, including RYTARY. Tell patients to inform their healthcare provider if they develop symptoms such as depression, confusion, cheilosis, glossitis, dermatitis, anemia, neuropathy, and/or seizures [see Warnings and Precautions (5.7) ] .

Hypotension and Syncope Advise patients that they may develop orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sweating [see Adverse Reactions (6.1) ] . Advise patients to rise slowly after sitting or lying down, especially if they have been doing so for a prolonged period. Advise patients of the possible additive sedative effects when taking other CNS depressants in combination with RYTARY.

Pregnancy and Breastfeeding Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during RYTARY therapy [see Use in Specific Populations ( 8.1 ) ] . Advise female patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant [see Use in Specific Populations ( 8.2 ) ] . Manufactured by: Bora Pharmaceutical Laboratories Inc.

Jhunan, Taiwan Or Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Distributed by: Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Copyright 2019 Amneal Pharmaceuticals LLC All rights reserved Rev.

03-2026-02 1566-05

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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