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Dhivy Carbidopa Levodopa 25 mg; 100 mg Tablet, 100-count — NDC 75854-0701-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dhivy Carbidopa Levodopa 25 mg; 100 mg Tablet, 100-count — NDC 75854-701-01 (Billing 75854-0701-01)

by Avion Pharmaceuticals, LLC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Dhivy Carbidopa Levodopa 25 mg; 100 mg Tablet from Avion Pharmaceuticals, LLC, marketed since Jul 2022 and currently FDA-listed; retail pharmacies pay about $3.61 per tablet (NADAC). It is this product's only package size.

NDC 75854-0701-01
🏷️ FDA NDC (as labeled) 75854-701-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 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

NDC database record

One package, one record: these facts belong to NDC 75854-701-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
75854 labeler · 701 product · 01 package
Package marketed since
Jul 13, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
100 EA per package
Barcode (UPC)
0375854701015
Medicaid fills, this package
22 prescriptions in the last four reported quarters
FDA record last changed
Sep 3, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 75854-701-01
Product NDC 75854-701
11-digit billing NDC 75854070101
NCPDP billing unit EA — each (per item)
RxCUI 197444, 2586032
UNII MNX7R8C5VO, 46627O600J
UPC 0375854701015
Application # NDA214869
SPL Set ID 39d79ade-8ee0-40ba-9fdd-13045b8ddbdf
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 2022-07-13
Route ORAL
Dosage form TABLET
Substance CARBIDOPA HYDRATE; LEVODOPA

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 002538
GCN 62741
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 DHIVY 25-100 MG TABLET
FDB brand name Dhivy
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002538
  • GCN: 62741
  • HICL (First Databank): 013894
  • AHFS class code: 28:36.16.00
  • RxCUI (RxNorm): 197444
Why two NDCs? The FDA registers this code as 75854-701-01 — 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 → 75854-0701-01. 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.

Clinical

Label name DHIVY 25-100 MG TABLET 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
  • It treats Parkinson’s disease and related parkinsonism, including parkinsonism after brain inflammation or carbon monoxide or manganese poisoning. Duopa is specifically for motor f...
  • Follow your prescription exactly, since your doctor adjusts the dose slowly. Extended-release forms shouldn’t be chewed or crushed. Rytary and Crexont can be taken with or without...
  • Nausea, dizziness, headache, vivid dreams, and uncontrolled movements called dyskinesia are common. Tell your doctor if these bother you, because a dose change may help.
  • Be careful. Some people fall asleep suddenly with no warning, even after being on it a long time. If that happens, don’t drive or do risky activities, and tell your doctor.
📖 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.

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 eaPer package
Retail pharmacies payNADAC · weekly $3.614 $361.41 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $3.51 $351.23 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2026 $3.614 $3.614
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
75854-0701-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2022-02-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Carbidopa and levodopa 25 mg/1; 100 mg 00093-9702-01 Teva 100 tablets $0.076 AB Availability likely save 98%
Carbidopa and Levodopa 25 mg/1; 100 mg 00904-7501-61 Major 100 tablets $0.076 AB Availability likely save 98%
Carbidopa And Levodopa 25 mg/1; 100 mg 31722-0382-01 Camber 100 tablets $0.076 AB Availability likely save 98%
Carbidopa and Levodopa 25 mg/1; 100 mg 50228-0458-01 ScieGen 100 tablets $0.076 AB Availability likely save 98%
Carbidopa-levodopa 25 mg/1; 100 mg 52817-0391-00 TruPharma, 1000 tablets $0.076 AB Availability likely save 98%
Carbidopa and Levodopa 25 mg/1; 100 mg 59651-0457-01 Aurobindo 100 tablets $0.076 AB Availability likely save 98%
Carbidopa and Levodopa 25 mg/1; 100 mg 60687-0661-01 American 100 tablets $0.076 AB Availability likely save 98%
Carbidopa and Levodopa 25 mg/1; 100 mg 69367-0339-01 Westminster 100 tablets $0.076 AB Availability likely save 98%
Carbidopa-levodopa 25 mg/1; 100 mg 72888-0107-00 Advagen 1000 tablets $0.076 AB Availability likely save 98%
Carbidopa and Levodopa 25 mg/1; 100 mg 75907-0020-01 Dr. 100 tablets $0.076 AB Availability likely save 98%
Sinemet 25 mg/1; 100 mg 78206-0168-01 Organon 100 tablets $1.424 AB Discontinued save 61%
Sinemet 25 mg/1; 100 mg 78206-0190-01 Organon 100 tablets $1.424 AB Availability likely save 61%
Dhivy 25 mg/1; 100 mgthis 75854-0701-01 Avion 100 tablets $3.614 — Availability likely —
Carbidopa and Levodopa 25 mg/1; 100 mg 00615-8536-05 NCS 15 tablets — AB FDA listed —
Carbidopa and levodopa 25 mg/1; 100 mg 42291-0472-01 AvKARE 100 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-5969-01 A-S 90 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-6580-01 A-S 90 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-6725-00 A-S 90 tablets — AB FDA listed —
Carbidopa and levodopa 25 mg/1; 100 mg 50090-6727-00 A-S 90 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-7498-01 A-S 90 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-7499-00 A-S 90 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 50268-0202-15 AvPAK 50 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 55154-2643-00 Cardinal 10 tablets — AB FDA listed —
Carbidopa And Levodopa 25 mg/1; 100 mg 62756-0518-08 Sun 100 tablets — AB FDA listed —
Carbidopa And Levodopa 25 mg/1; 100 mg 63629-2356-01 Bryant 500 tablets — AB Discontinued —
Carbidopa And Levodopa 25 mg/1; 100 mg 63629-2357-01 Bryant 100 tablets — AB Discontinued —
Carbidopa-levodopa 25 mg/1; 100 mg 67046-1507-03 Coupler 30 tablets — AB FDA listed —
Carbidopa And Levodopa 25 mg/1; 100 mg 68071-2240-01 NuCare 100 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 71205-0878-00 Proficient 100 tablets — AB FDA listed —
Carbidopa-levodopa 25 mg/1; 100 mg 71335-2588-01 Bryant 90 tablets — AB FDA listed —
Carbidopa and Levodopa 25 mg/1; 100 mg 71610-0647-60 Aphena 90 tablets — AB FDA listed —
Carbidopa and levodopa 25 mg/1; 100 mg 71610-0664-60 Aphena 90 tablets — AB FDA listed —
Carbidopa And Levodopa 25 mg/1; 100 mg 72865-0362-01 XLCare 100 tablets — AB FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2021
First FDA approval
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 12, 2021 RLD RS ⏳ ~12.5 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 11819485 — method of use (U-3557)
US 11439613 — method of use (U-3557)
US 11033521 — method of use (U-219)
US 11033521 — method of use (U-3304)
US 11033521 — method of use (U-3305)
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
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 (5)
PatentTypeUse codeExpires
US 11819485 ↗ Method of use U-3557 Mar 28, 2039
US 11439613 ↗ Method of use U-3557 Mar 28, 2039
US 11033521 ↗ Method of use U-219 Mar 28, 2039
US 11033521 ↗ Method of use U-3304 Mar 28, 2039
US 11033521 ↗ Method of use U-3305 Mar 28, 2039
Common questions
Is there a generic version of DHIVY 25-100 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for DHIVY 25-100 MG TABLET. See the alternatives section for substitutable, lower-cost products.
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.

What it looks like

Color white
ShapeCapsule
ImprintAV701
Size19 mm
ScoringScored — splits in 4
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 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 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

3 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.

Manufacturer & labeler

LabelerAvion Pharmaceuticals, LLC
Application holderAVION PHARMACEUTICALS LLC
FDA applicationNDA214869 (NDA)
Labeler code75854
First marketedJul 2022
Product typeHuman Prescription Drug
Portfolio13 products on file

More NDCs from Avion Pharmaceuticals, LLC labeler code 75854

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 69 words ▾

1 INDICATIONS AND USAGE DHIVY is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. DHIVY 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 symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) The recommended starting dosage of DHIVY is one 25 mg /100 mg tablet taken orally three times a day. ( 2.2 ) Dosage may be increased by up to one whole tablet every day or every other day, as needed, until a maximum dosage of eight whole tablets of DHIVY a day is reached. ( 2.2 ) Swallow DHIVY with or without food. ( 2.4 )

2.1Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating treatment with carbidopa-levodopa therapies including DHIVY, 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 DHIVY while supplementing vitamin B6.

2.2Initial Dosage and Maintenance of Therapy The recommended starting dosage of DHIVY is one 25 mg / 100 mg tablet taken orally three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by up to one whole tablet every day or every other day, as needed to a maximum daily dosage of eight whole tablets.

Dosing with DHIVY should be individualized and adjusted according to clinical response and tolerability. The tablet is functionally scored to facilitate dose adjustment. At least 70 mg to 100 mg of carbidopa per day should be provided.

Experience with total daily dosages of carbidopa greater than 200 mg is limited. Monitor patients closely during the dose adjustment period. Specifically, involuntary movements may occur with DHIVY, which may require dosage reduction.

Blepharospasm may be a useful early sign of excess dosage in some patients. Maintain patients on the lowest dosage required to achieve symptomatic control and to minimize adverse reactions, such as dyskinesia and nausea.

2.3Discontinuation of DHIVY Avoid sudden discontinuation or rapid dose reduction of DHIVY. The daily dosage of DHIVY should be tapered at the time of treatment discontinuation [see Warnings and Precautions ( 5.2 ) ] . If general anesthesia is required, DHIVY may be continued as long as the patient is permitted to take fluids and medication by mouth.

If therapy is interrupted temporarily, the patient should be observed for symptoms resembling neuroleptic malignant syndrome, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

2.4Administration Information Swallow DHIVY with or without food. The patient should be advised that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. If the patient has difficulty swallowing the tablet due to its size, the tablet can be broken at the score lines.

💊 Dosage Forms and Strengths 73 words ▾

3 DOSAGE FORMS AND STRENGTHS DHIVY tablets are white to off-white tablets containing 25 mg of carbidopa and 100 mg of levodopa. Each DHIVY tablet has 3 functional scores with each segment containing 6.25 mg of carbidopa and 25 mg of levodopa. Tablets: Carbidopa and levodopa 25 mg/100 mg, functionally scored. Each DHIVY tablet has 3 functional scores with each segment containing 6.25 mg of carbidopa and 25 mg of levodopa.( 3 )

⛔ Contraindications 77 words ▾

4 CONTRAINDICATIONS DHIVY is contraindicated in patients Currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, linezolid, 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 )] . With known hypersensitivity to any component of DHIVY [see Adverse Reactions (6 )].

Nonselective MAO inhibitors ( 4 ) With known hypersensitivity to any component of DHIVY ( 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 Ischemic Events: Monitor patients with a history of cardiovascular disease ( 5.3 ) Hallucinations/Psychosis may occur ( 5.4 ) Impulse Control/Compulsive Behaviors: Consider dose reduction or stopping DHIVY if impulse control disorders occur ( 5.5 ) May cause or exacerbate dyskinesia: Consider dose reduction ( 5.6 )

5.1Falling Asleep During Activities of Daily Living and Somnolence Patients taking carbidopa/levodopa alone or with other dopaminergic drugs have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living, including the operation of motor vehicles which have resulted in accidents. Although many patients reported somnolence while on dopaminergic medications, 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.

Sudden onset of sleep has been reported to occur more than one year after the 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 some patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness in DHIVY-treated patients, especially since some of the events occur well after the start of treatment.

Prescribers should be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Before initiating treatment with DHIVY, advise patients about the potential to develop drowsiness and ask specifically about factors that may increase the risk for somnolence with DHIVY such as the use of concomitant sedating medications and the presence of sleep disorders. Consider discontinuing DHIVY in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.).

If treatment with DHIVY continues, advise patients 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 DHIVY. If the decision is made to discontinue DHIVY, the dose should be tapered to reduce the risk of hyperpyrexia and confusion [see Dosage and Administration ( 2.3 ) ] .

5.3Cardiovascular Ischemic Events 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 period of initial dosage adjustment.

5.4Hallucinations/Psychotic-Like Behavior Hallucinations and psychotic-like behavior have been reported with dopaminergic medications. In general, hallucinations present shortly after the initiation of therapy and may be responsive to dose reduction in levodopa. Hallucinations may be accompanied by confusion, sleep disorder (insomnia), and excessive dreaming.

Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, d… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 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/Psychotic-Like Behavior [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 )] Depression/Suicidality [see Warnings and Precautions ( 5.11 )] The most common adverse reactions reported with carbidopa/levodopa tablets have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea.

The following other adverse reactions have been reported with carbidopa/levodopa tablets: Body as a Whole Chest pain, asthenia. Cardiovascular Cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation. Gastrointestinal Dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations.

Hematologic Agranulocytosis, hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia. Hypersensitivity Angioedema, urticaria, pruritus, Henoch-Schönlein purpura, bullous lesions (including pemphigus-like reactions). Musculoskeletal Back pain, shoulder pain, muscle cramps.

Nervous System/Psychiatric Psychotic episodes including delusions, hallucinations, and paranoid ideation, bradykinetic episodes (“on-off” phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms, seizures (including convulsions). Respiratory Dyspnea, upper respiratory infection. Skin Rash, increased sweating, alopecia, dark sweat.

Urogenital Urinary tract infection, urinary frequency, dark urine. Laboratory Tests Decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), LDH, bilirubin, BUN, Coombs test; elevated serum glucose; white blood cells, bacteria, and blood in the urine. Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulations, and may occur with DHIVY are: Body as a Whole Abdominal pain and distress, fatigue.

Cardiovascular Myocardial infarction. Gastrointestinal Gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups. Metabolic Edema, weight gain, weight loss.

Musculoskeletal Leg pain. Nervous System/Psychiatric Ataxia, extrapyramidal disorder, falling, anxiety, gait abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation, euphoria, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, increased tremor, numbness, muscle twitching, activation of latent Horner’s syndrome, peripheral neuropathy. Respiratory Pharyngeal pain, cough.

Skin Malignant melanoma, flushing. Special Senses Oculogyric crises, diplopia, blurred vision, dilated pupils. Urogenital Urinary retention, urinary incontinence, priapism.

Miscellaneous Bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes, sense of stimulation. The most common adverse reactions reported with carbidopa/levodopa tablets have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea ( 6 ). To report SUSPECTED ADVE… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

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

7.1Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with DHIVY is contraindicated [see Contraindications ( 4 ) ] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating DHIVY. DHIVY may be administered concomitantly with the manufacturer's recommended dose of selective MAO-B inhibitors (e.g., rasagiline or selegiline HCl).

Concomitant therapy with selegiline and carbidopa/levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa/levodopa alone.

7.2Dopamine D 2 Receptor Antagonists and Isoniazid Dopamine D 2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the effectiveness of levodopa. Monitor patients taking these drugs with DHIVY 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 DHIVY. If iron salts or multivitamins containing iron salts are co-administered with DHIVY, monitor patients for worsening Parkinson’s symptoms.

7.4Antihypertensive Drugs Symptomatic postural hypotension occurred when carbidopa/levodopa was added to the treatment of a patient receiving antihypertensive drugs. Therefore, when therapy with DHIVY is started, dosage adjustment of the antihypertensive drug may be required.

7.5Dopamine-Depleting Agents Use of DHIVY with dopamine-depleting agents (e.g., reserpine and tetrabenazine) or other drugs known to deplete monoamine stores is not recommended.

7.6Metoclopramide Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also reduce effectiveness of levodopa by its dopamine receptor antagonistic properties.

👥 Use in Specific Populations ~2 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 DHIVY 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 malformations 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.

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.

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

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

8.5Geriatric Use Of the total number of subjects in clinical studies of immediate-release carbidopa-levodopa tablets (i.e., Sinemet ® ), almost half of the patients were older than age 65 years, and few were age 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals to adverse drug reactions such as hallucinations cannot be ruled out. The systemic exposure of levodopa was increased in elderly subjects compared to young subjects [see Clinical Pharmacology ( 12.3 ) ] .

There is no specific dosing recommendation based upon clinical pharmacology data as carbidopa/levodopa is titrated as tolerated for clinical effect.

🆘 Overdosage 125 words ▾

10 OVERDOSAGE 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 ~3 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 treats 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. Carbidopa does not cross the blood-brain barrier and does not affect the metabolism of levodopa within the central nervous system. 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 Following single oral administration of a DHIVY tablet, DHIVY was shown to be bioequivalent to an immediate-release carbidopa/levodopa 25/100 mg tablet under fasting conditions for both carbidopa and levodopa. Absorption Following oral dosing of DHIVY under fasted conditions, the maximum concentration occurred at 3 hours for carbidopa and 1 hour for levodopa. The exposure of DHIVY after dose fractionation is proportional.

Effect of Food In healthy adults, oral administration of DHIVY after a high-fat, high-calorie meal reduced levodopa C max by approximately 25% while the AUC remained unchanged. The peak concentration of both carbidopa/levodopa were observed approximately 30 minutes later when DHIVY is taken with a high-fat, high-calorie meal. Since levodopa competes with certain amino acids for transport across the gut wall, the absorption of levodopa may be impaired in some patients on a high protein diet [see Dosage and Administration ( 2.4 ) ] .

Distribution Carbidopa is approximately 36% bound to plasma proteins. Levodopa is approximately 10% to 30% bound to plasma proteins. Elimination Following oral dosing of DHIVY under fasted conditions, the half-life was reported at approximately 3.5 hours for carbidopa and 2 hours for levodopa.

In clinical pharmacologic studies, simultaneous administration of carbidopa and levodopa produced greater urinary excretion of levodopa in proportion to the excretion of dopamine than administration of the two drugs at separate times. Specific Populations Geriatric Patients A study in eight young healthy subjects (21-22 years) and eight elderly healthy subjects (69-76 years) showed that the absolute bioavailability of levodopa was similar between young and elderly subjects following oral administration of levodopa and carbidopa.

However, the systemic exposure (AUC) of levodopa was increased by 55% in elderly subjects compared to young subjects. Based on another study in forty patients with Parkinson’s disease, there was a correlation between age of patients and the increase of AUC of levodopa following administration of levodopa and an inhibitor of peripheral dopa decarboxylase. AUC of levodopa was increased by 28% in elderly patients (≥ 65 years) compared to young patients (< 65 years).

Additionally, mean value of C max for levodopa was increased by 24% in elderly patients (≥ 65 years) compared to young patients (< 65 years) [see Use in Specific Populations ( 8.5 ) ] . The AUC of carbidopa was increased in elderly subjects (n=10, 65-76 years) by 29% compared to young subjects (n=24, 23-64 years) following IV administration of 50 mg lev… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 138 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied DHIVY (carbidopa and levodopa) tablets are white to off-white tablets with functional scoring containing 25 mg of carbidopa and 100 mg of levodopa. One side of each DHIVY tablet has 3 scores, with each segment containing 6.25 mg of carbidopa and 25 mg of levodopa (1:4 ratio). The unscored side of the tablet is debossed with logo “AV70l”.

DHIVY is supplied as follows: NDC 75854-701-01 bottles of 100. Four copies of the Instructions for Use are included with the bottle, and additional copies, as needed, can be printed.

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 light-resistant container.

📋 Description 172 words ▾

11 DESCRIPTION DHIVY ® (carbidopa levodopa) is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in tablets for oral use. Carbidopa is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (–)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxy-benzene) propanoic acid monohydrate.

It has a pKa of 2.3. Its molecular formula is C 10 H 14 N 2 O 4 •H 2 O and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2.

It is designated chemically as (–)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. It has a pKa of 2.32. Its molecular formula is C 9 H 11 NO 4 and its structural formula is: DHIVY is supplied as tablets for oral administration containing 25 mg of carbidopa and 100 mg of levodopa.

The inactive ingredients are magnesium stearate, microcrystalline cellulose, and pregelatinized starch. 4e672b0d-figure-01 4e672b0d-figure-02

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Dosing Instructions It is important that DHIVY be taken at regular intervals according to the schedule outlined by their physician. Inform the patient not to change the prescribed dosage regimen and not to add any additional antiparkinson medications, including other carbidopa-levodopa preparations, without first consulting their physician.

Advise patients to call their healthcare provider before stopping DHIVY. Discontinue DHIVY slowly. Tell patients to call their healthcare provider if they develop withdrawal symptoms such as fever and confusion [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 )] .

Advise patients to swallow DHIVY with or without food. If the patient has difficulty swallowing the tablet due to its size, inform the patient that the tablet can be broken at the score lines [see Dosage and Administration ( 2.4 )]. Advise the patient that occasionally, dark color (red, brown, or black) may appear in saliva, urine, or sweat after ingestion of DHIVY.

Although the color appears to be clinically insignificant, garments may become discolored. Advise the patient that a change in diet to foods that are high in protein or taking iron salts or multivitamins with iron may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa.

Falling Asleep Advise patients that certain side effects such as sleepiness and dizziness that have been reported with DHIVY may affect some patients’ ability to drive and operate machinery safely [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6 ) ]. 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 DHIVY [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 DHIVY. 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 )] .

Pregnancy and Breastfeeding Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during DHIVY 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 ) ]. Distributed by: Avion Pharmaceuticals, LLC Alpharetta, GA, 30005 USA L-0044 Rev.

0326-01 201131-01 INSTRUCTIONS FOR USE DHIVY (DHI-VEE) (carbidopa and levodopa) tablets, for oral use This Instructions for Use contains information on how to take DHIVY. Important Information You Need to Know Before Taking DHIVY Take DHIVY exactly as your healthcare provider tells you to take it. Your healthcare provider may increase your dose every day or every other day as needed until you reach the recommended dosage.

Take DHIVY by mouth, with or without food. 1 whole DHIVY tablet contains 25 mg of carbidopa and 100 mg of levodopa. 1 DHIVY tablet has 3 grooves (score lines) that can be split into 4 segments so that you can take your prescribed dose.

(See the DHIVY tablet image below.) If… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies 36 words ▾

14 CLINICAL STUDIES The efficacy of DHIVY is based upon bioavailability studies comparing DHIVY to an immediate-release tablet containing 25 mg of carbidopa and 100 mg of levodopa [see Clinical Pharmacology ( 12.3 ) ] .

🧪 Nonclinical Toxicology 41 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In rats, oral administration of carbidopa-levodopa for two years resulted in no evidence of carcinogenicity. Impairment of Fertility In reproduction studies, no effects on fertility were observed in rats receiving carbidopa-levodopa.

📄 Recent Major Changes 27 words ▾

RECENT MAJOR CHANGES Dosage and Administration (2.1) 03/2026 Warnings and Precautions (5.7) 03/2026 Dosage and Administration ( 2.1 ) 03/2026 Warnings and Precautions ( 5.7 ) 03/2026

📄 Package Label / Principal Display Panel 9 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Dhivy Bottle Label Rev. 0626-01

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
22
Units reimbursed last 4 qtrs
2.9K
Gross reimbursed last 4 qtrs
$10.3K
Avg / prescription
$469.85
Avg / unit
$3.5123
Latest quarter Q4 2025
11Rx
Medicaid pays / ea
$3.5123
gross reimbursed
vs
NADAC / ea
$3.6141
acquisition cost
=
Spread
−$0.1018
-3% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 22 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 2,943 units · 15.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
15.015.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 15.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Dhivy — 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 Dhivy. 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
$238.7K
Claims incl. refills
380
Beneficiaries
238
Spend / beneficiary
$1,002.81
Spend / claim
$628.07
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 Dhivy (this brand).

Top reported reactions

Hallucination479
Fall436
Death370
Confusional State217
Dizziness202
Fatigue199
Parkinson^s Disease195

Age at onset

Adolescent1
Adult71
Elderly200

Reporter sex

3,541 reports
Male · 61%
Female · 39%
Unknown · 0%

Serious outcomes

Hospitalization1,035
Death566
Life-threatening30
Disabling22
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 638 4
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.
← 75854-0604-01 · Avion 75855-3470-01 · CIMBAR →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.