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CREXONT carbidopa and levodopa 52.5 mg; 210 mg Capsule, Extended Release, 120-count — NDC 64896-0968-23 package photo

CREXONT carbidopa and levodopa 52.5 mg; 210 mg Capsule, Extended Release, 120-count

by Amneal Pharmaceuticals LLC · 1 BOTTLE in 1 CARTON (64896-968-23) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
NDC 64896-0968-23
🏷️ FDA NDC (as labeled) 64896-968-23 billing pads the product segment with a zero
This package
Contains120-count Pack sizes2 compare ↓
Also priced by: Part D plans $4.46/unit — full pricing hub ↓
Also comes in: 120 capsules 64896-0968-16
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) 64896-968-23
Product NDC 64896-968
11-digit billing NDC 64896096823
RxCUI 2690259, 2690265, 2690279, 2690281, 2690284, 2690286, 2690290, 2690292
UNII 46627O600J, MNX7R8C5VO
UPC 0364896968166, 0364896969163, 0364896967169
Application # NDA217186
SPL Set ID 095a08b6-b0b8-4f88-b759-67e8b87287a0
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 2024-08-09
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance CARBIDOPA HYDRATE; LEVODOPA
GPI-14 73209902100244
GCN Seq No 086405
GCN 56114
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 CREXONT ER 52.5 MG-210 MG CAP
FDB brand name Crexont
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 64896-968-23 — 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 → 64896-0968-23. 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 applicationNDA217186 (NDA)
Labeler code64896
First marketedAug 2024
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 CREXONT ER 52.5 MG-210 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 white / yellow / green / purple / orange
ShapeCapsule
ImprintIPX203;350
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 3J2P07GVB6
    Cellulose acetate is a plant-derived polymer made by chemically modifying cellulose fibers. In medications, it serves as a film-coating material for tablets and capsules to protect the drug, control release, and improve appearance.
  • UNII D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • 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 905HNO1SIH
    A synthetic polymer made from methacrylate compounds that forms a film coating on tablets or capsules. It helps control how quickly the medicine dissolves and releases its active ingredient in the digestive system.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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 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 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 $4.46 $534.68 / 120 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
Crexont 52.5 mg/1; 210 mgthis 64896-0968-23 Amneal 120 capsules — — 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

🏛️
2024
First FDA approval
Aug 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2041
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 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 7, 2024 RLD RS ⏳ ~15.3 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 12303482 — method of use (U-1649)
US 12303482 — method of use (U-4005)
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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 (248)
PatentTypeUse codeExpires
US 12303482 ↗ Method of use U-1649 Dec 21, 2041
US 12303482 ↗ Method of use U-4005 Dec 21, 2041
US 12303482 ↗ Method of use U-4005 Dec 21, 2041
US 12303482 ↗ Method of use U-4005 Dec 21, 2041
US 12303482 ↗ Method of use U-4005 Dec 21, 2041
US 12303482 ↗ Method of use U-4004 Dec 21, 2041
US 12303482 ↗ Method of use U-4004 Dec 21, 2041
US 12303482 ↗ Method of use U-4004 Dec 21, 2041
US 12303482 ↗ Method of use U-4004 Dec 21, 2041
US 12303482 ↗ Method of use U-219 Dec 21, 2041
US 12303482 ↗ Method of use U-219 Dec 21, 2041
US 12303482 ↗ Method of use U-219 Dec 21, 2041
US 12303482 ↗ Method of use U-219 Dec 21, 2041
US 12303482 ↗ Method of use U-1649 Dec 21, 2041
US 12303482 ↗ Method of use U-1649 Dec 21, 2041
US 12303482 ↗ Method of use U-1649 Dec 21, 2041
US 12295931 ↗ Method of use U-1649 Dec 21, 2041
US 12295931 ↗ Method of use U-4005 Dec 21, 2041
US 12295931 ↗ Method of use U-4005 Dec 21, 2041
US 12295931 ↗ Method of use U-4005 Dec 21, 2041
US 12295931 ↗ Method of use U-4005 Dec 21, 2041
US 12295931 ↗ Method of use U-4004 Dec 21, 2041
US 12295931 ↗ Method of use U-4004 Dec 21, 2041
US 12295931 ↗ Method of use U-4004 Dec 21, 2041
US 12295931 ↗ Method of use U-4004 Dec 21, 2041
US 12295931 ↗ Method of use U-219 Dec 21, 2041
US 12295931 ↗ Method of use U-219 Dec 21, 2041
US 12295931 ↗ Method of use U-219 Dec 21, 2041
US 12295931 ↗ Method of use U-219 Dec 21, 2041
US 12295931 ↗ Method of use U-1649 Dec 21, 2041
US 12295931 ↗ Method of use U-1649 Dec 21, 2041
US 12295931 ↗ Method of use U-1649 Dec 21, 2041
US 12303481 ↗ Method of use U-1649 Dec 21, 2041
US 12303481 ↗ Method of use U-1649 Dec 21, 2041
US 12303481 ↗ Method of use U-1649 Dec 21, 2041
US 12303481 ↗ Method of use U-1649 Dec 21, 2041
US 12303481 ↗ Method of use U-219 Dec 21, 2041
US 12303481 ↗ Method of use U-219 Dec 21, 2041
US 12303481 ↗ Method of use U-219 Dec 21, 2041
US 12303481 ↗ Method of use U-219 Dec 21, 2041
US 12303481 ↗ Method of use U-4004 Dec 21, 2041
US 12303481 ↗ Method of use U-4004 Dec 21, 2041
US 12303481 ↗ Method of use U-4004 Dec 21, 2041
US 12303481 ↗ Method of use U-4004 Dec 21, 2041
US 12303481 ↗ Method of use U-4005 Dec 21, 2041
US 12303481 ↗ Method of use U-4005 Dec 21, 2041
US 12303481 ↗ Method of use U-4005 Dec 21, 2041
US 12303481 ↗ Method of use U-4005 Dec 21, 2041
US 11986449 ↗ Method of use U-219 Dec 21, 2041
US 11986449 ↗ Method of use U-219 Dec 21, 2041
US 11986449 ↗ Method of use U-219 Dec 21, 2041
US 11986449 ↗ Method of use U-219 Dec 21, 2041
US 11666538 ↗ Method of use U-219 Oct 7, 2034
US 11666538 ↗ Method of use U-219 Oct 7, 2034
US 11666538 ↗ Method of use U-219 Oct 7, 2034
US 11666538 ↗ Method of use U-219 Oct 7, 2034
US 10987313 ↗ Method of use U-219 Oct 7, 2034
US 10987313 ↗ Method of use U-219 Oct 7, 2034
US 10987313 ↗ Method of use U-219 Oct 7, 2034
US 10987313 ↗ Method of use U-219 Oct 7, 2034
US 10973769 ↗ Method of use U-219 Oct 7, 2034
US 10973769 ↗ Method of use U-219 Oct 7, 2034
US 10973769 ↗ Method of use U-219 Oct 7, 2034
US 10973769 ↗ Method of use U-219 Oct 7, 2034
US 10688058 ↗ Method of use U-219 Oct 7, 2034
US 10688058 ↗ Method of use U-219 Oct 7, 2034
US 10688058 ↗ Method of use U-219 Oct 7, 2034
US 10688058 ↗ Method of use U-219 Oct 7, 2034
US 10292935 ↗ Method of use U-219 Oct 7, 2034
US 10292935 ↗ Method of use U-219 Oct 7, 2034
US 10292935 ↗ Method of use U-219 Oct 7, 2034
US 10292935 ↗ Method of use U-219 Oct 7, 2034
US 10098845 ↗ Method of use U-219 Oct 7, 2034
US 10098845 ↗ Method of use U-219 Oct 7, 2034
US 10098845 ↗ Method of use U-219 Oct 7, 2034
US 10098845 ↗ Method of use U-219 Oct 7, 2034
US 12201596 ↗ Method of use U-1649 Dec 21, 2041
US 12201596 ↗ Method of use U-1649 Dec 21, 2041
US 12201596 ↗ Method of use U-1649 Dec 21, 2041
US 12201596 ↗ Method of use U-1649 Dec 21, 2041
US 12201596 ↗ Method of use U-4004 Dec 21, 2041
US 12201596 ↗ Method of use U-4004 Dec 21, 2041
US 12201596 ↗ Method of use U-4004 Dec 21, 2041
US 12201596 ↗ Method of use U-4004 Dec 21, 2041
US 12201596 ↗ Method of use U-4005 Dec 21, 2041
US 12201596 ↗ Method of use U-4005 Dec 21, 2041
US 12201596 ↗ Method of use U-4005 Dec 21, 2041
US 12201596 ↗ Method of use U-4005 Dec 21, 2041
US 12178919 ↗ Method of use U-219 Oct 7, 2034
US 12178919 ↗ Method of use U-219 Oct 7, 2034
US 12178919 ↗ Method of use U-219 Oct 7, 2034
US 12178919 ↗ Method of use U-219 Oct 7, 2034
US 12109185 ↗ Method of use U-1649 Dec 21, 2041
US 12109185 ↗ Method of use U-1649 Dec 21, 2041
US 12109185 ↗ Method of use U-1649 Dec 21, 2041
US 12109185 ↗ Method of use U-1649 Dec 21, 2041
US 12109185 ↗ Method of use U-219 Dec 21, 2041
US 12109185 ↗ Method of use U-219 Dec 21, 2041
US 12109185 ↗ Method of use U-219 Dec 21, 2041
US 12109185 ↗ Method of use U-219 Dec 21, 2041
US 12109185 ↗ Method of use U-4004 Dec 21, 2041
US 12109185 ↗ Method of use U-4004 Dec 21, 2041
US 12109185 ↗ Method of use U-4004 Dec 21, 2041
US 12109185 ↗ Method of use U-4004 Dec 21, 2041
US 12109185 ↗ Method of use U-4005 Dec 21, 2041
US 12109185 ↗ Method of use U-4005 Dec 21, 2041
US 12109185 ↗ Method of use U-4005 Dec 21, 2041
US 12109185 ↗ Method of use U-4005 Dec 21, 2041
US 12458616 ↗ Method of use U-1649 Dec 21, 2041
US 12458616 ↗ Method of use U-4005 Dec 21, 2041
US 12458616 ↗ Method of use U-4005 Dec 21, 2041
US 12458616 ↗ Method of use U-4005 Dec 21, 2041
US 12458616 ↗ Method of use U-4005 Dec 21, 2041
US 12458616 ↗ Method of use U-4004 Dec 21, 2041
US 12458616 ↗ Method of use U-4004 Dec 21, 2041
US 12458616 ↗ Method of use U-4004 Dec 21, 2041
US 12458616 ↗ Method of use U-4004 Dec 21, 2041
US 12458616 ↗ Method of use U-219 Dec 21, 2041
US 12458616 ↗ Method of use U-219 Dec 21, 2041
US 12458616 ↗ Method of use U-219 Dec 21, 2041
US 12458616 ↗ Method of use U-219 Dec 21, 2041
US 12458616 ↗ Method of use U-1649 Dec 21, 2041
US 12458616 ↗ Method of use U-1649 Dec 21, 2041
US 12458616 ↗ Method of use U-1649 Dec 21, 2041
US 12453710 ↗ Method of use U-4005 Dec 21, 2041
US 12453710 ↗ Method of use U-4005 Dec 21, 2041
US 12453710 ↗ Method of use U-4005 Dec 21, 2041
US 12453710 ↗ Method of use U-4005 Dec 21, 2041
US 12263148 ↗ Method of use U-1649 Dec 21, 2041
US 12263148 ↗ Method of use U-4004 Dec 21, 2041
US 12263148 ↗ Method of use U-219 Dec 21, 2041
US 12263148 ↗ Method of use U-1649 Dec 21, 2041
US 12263148 ↗ Method of use U-1649 Dec 21, 2041
US 12263148 ↗ Method of use U-1649 Dec 21, 2041
US 12263148 ↗ Method of use U-219 Dec 21, 2041
US 12263148 ↗ Method of use U-219 Dec 21, 2041
US 12263148 ↗ Method of use U-219 Dec 21, 2041
US 12263148 ↗ Method of use U-4004 Dec 21, 2041
US 12263148 ↗ Method of use U-4004 Dec 21, 2041
US 12263148 ↗ Method of use U-4004 Dec 21, 2041
US 12263148 ↗ Method of use U-4005 Dec 21, 2041
US 12263148 ↗ Method of use U-4005 Dec 21, 2041
US 12263148 ↗ Method of use U-4005 Dec 21, 2041
US 12263148 ↗ Method of use U-4005 Dec 21, 2041
US 12263149 ↗ Method of use U-1649 Dec 21, 2041
US 12263149 ↗ Method of use U-1649 Dec 21, 2041
US 12263149 ↗ Method of use U-1649 Dec 21, 2041
US 12263149 ↗ Method of use U-1649 Dec 21, 2041
US 12263149 ↗ Method of use U-219 Dec 21, 2041
US 12263149 ↗ Method of use U-219 Dec 21, 2041
US 12263149 ↗ Method of use U-219 Dec 21, 2041
US 12263149 ↗ Method of use U-219 Dec 21, 2041
US 12263149 ↗ Method of use U-4004 Dec 21, 2041
US 12263149 ↗ Method of use U-4004 Dec 21, 2041
US 12263149 ↗ Method of use U-4004 Dec 21, 2041
US 12263149 ↗ Method of use U-4004 Dec 21, 2041
US 12263149 ↗ Method of use U-4005 Dec 21, 2041
US 12263149 ↗ Method of use U-4005 Dec 21, 2041
US 12263149 ↗ Method of use U-4005 Dec 21, 2041
US 12263149 ↗ Method of use U-4005 Dec 21, 2041
US 12453710 ↗ Method of use U-4004 Dec 21, 2041
US 12453710 ↗ Method of use U-4004 Dec 21, 2041
US 12453710 ↗ Method of use U-4004 Dec 21, 2041
US 12453710 ↗ Method of use U-4004 Dec 21, 2041
US 12453710 ↗ Method of use U-219 Dec 21, 2041
US 12453710 ↗ Method of use U-219 Dec 21, 2041
US 12453710 ↗ Method of use U-219 Dec 21, 2041
US 12453710 ↗ Method of use U-219 Dec 21, 2041
US 12453710 ↗ Method of use U-1649 Dec 21, 2041
US 12453710 ↗ Method of use U-1649 Dec 21, 2041
US 12453710 ↗ Method of use U-1649 Dec 21, 2041
US 12453710 ↗ Method of use U-1649 Dec 21, 2041
US 12447139 ↗ Method of use U-1649 Dec 21, 2041
US 12447139 ↗ Method of use U-1649 Dec 21, 2041
US 12447139 ↗ Method of use U-1649 Dec 21, 2041
US 12447139 ↗ Method of use U-1649 Dec 21, 2041
US 12447139 ↗ Method of use U-219 Dec 21, 2041
US 12447139 ↗ Method of use U-219 Dec 21, 2041
US 12447139 ↗ Method of use U-219 Dec 21, 2041
US 12447139 ↗ Method of use U-219 Dec 21, 2041
US 12447139 ↗ Method of use U-4004 Dec 21, 2041
US 12447139 ↗ Method of use U-4004 Dec 21, 2041
US 12447139 ↗ Method of use U-4004 Dec 21, 2041
US 12447139 ↗ Method of use U-4004 Dec 21, 2041
US 12447139 ↗ Method of use U-4005 Dec 21, 2041
US 12447139 ↗ Method of use U-4005 Dec 21, 2041
US 12447139 ↗ Method of use U-4005 Dec 21, 2041
US 12447139 ↗ Method of use U-4005 Dec 21, 2041
US 12194150 ↗ Method of use U-219 Dec 21, 2041
US 12194150 ↗ Method of use U-219 Dec 21, 2041
US 12194150 ↗ Method of use U-219 Dec 21, 2041
US 12194150 ↗ Method of use U-219 Dec 21, 2041
US 12370163 ↗ Method of use U-1649 Dec 21, 2041
US 12370163 ↗ Method of use U-1649 Dec 21, 2041
US 12370163 ↗ Method of use U-1649 Dec 21, 2041
US 12370163 ↗ Method of use U-1649 Dec 21, 2041
US 12370163 ↗ Method of use U-219 Dec 21, 2041
US 12370163 ↗ Method of use U-219 Dec 21, 2041
US 12370163 ↗ Method of use U-219 Dec 21, 2041
US 12370163 ↗ Method of use U-219 Dec 21, 2041
US 12370163 ↗ Method of use U-4004 Dec 21, 2041
US 12370163 ↗ Method of use U-4004 Dec 21, 2041
US 12370163 ↗ Method of use U-4004 Dec 21, 2041
US 12370163 ↗ Method of use U-4004 Dec 21, 2041
US 12370163 ↗ Method of use U-4005 Dec 21, 2041
US 12370163 ↗ Method of use U-4005 Dec 21, 2041
US 12370163 ↗ Method of use U-4005 Dec 21, 2041
US 12370163 ↗ Method of use U-4005 Dec 21, 2041
US 12128141 ↗ Method of use U-219 Oct 7, 2034
US 12128141 ↗ Method of use U-219 Oct 7, 2034
US 12128141 ↗ Method of use U-219 Oct 7, 2034
US 12128141 ↗ Method of use U-219 Oct 7, 2034
US 12491164 ↗ Drug product — Oct 7, 2034
US 12274793 ↗ Drug product — Oct 7, 2034
US 11622941 ↗ Drug product — Oct 7, 2034
US 12303605 ↗ Drug product — Oct 7, 2034
US 12274793 ↗ Drug product — Oct 7, 2034
US 12403099 ↗ Drug product — Oct 7, 2034
US 12491164 ↗ Drug product — Oct 7, 2034
US 12691074 ↗ Drug product — Oct 7, 2034
US 11622941 ↗ Drug product — Oct 7, 2034
US 12064521 ↗ Drug product — Oct 7, 2034
US 12178918 ↗ Drug product — Oct 7, 2034
US 12403099 ↗ Drug product — Oct 7, 2034
US 11622941 ↗ Drug product — Oct 7, 2034
US 12303605 ↗ Drug product — Oct 7, 2034
US 12064521 ↗ Drug product — Oct 7, 2034
US 12178918 ↗ Drug product — Oct 7, 2034
US 12691074 ↗ Drug product — Oct 7, 2034
US 12274793 ↗ Drug product — Oct 7, 2034
US 12178918 ↗ Drug product — Oct 7, 2034
US 12691074 ↗ Drug product — Oct 7, 2034
US 12064521 ↗ Drug product — Oct 7, 2034
US 12178918 ↗ Drug product — Oct 7, 2034
US 12303605 ↗ Drug product — Oct 7, 2034
US 12274793 ↗ Drug product — Oct 7, 2034
US 12403099 ↗ Drug product — Oct 7, 2034
US 12491164 ↗ Drug product — Oct 7, 2034
US 12403099 ↗ Drug product — Oct 7, 2034
US 12064521 ↗ Drug product — Oct 7, 2034
US 11357733 ↗ Drug product — Oct 7, 2034
US 11357733 ↗ Drug product — Oct 7, 2034
US 11357733 ↗ Drug product — Oct 7, 2034
US 11357733 ↗ Drug product — Oct 7, 2034
US 12491164 ↗ Drug product — Oct 7, 2034
US 12303605 ↗ Drug product — Oct 7, 2034
US 12691074 ↗ Drug product — Oct 7, 2034
US 11622941 ↗ Drug product — Oct 7, 2034
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductAug 7, 2027
NPNew ProductAug 7, 2027
NPNew ProductAug 7, 2027
NPNew ProductAug 7, 2027
Common questions
Is there a generic version of CREXONT ER 52.5 MG-210 MG CAP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CREXONT ER 52.5 MG-210 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 2041 — 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.
120 capsules64896-0968-16 431 Rx · $289,413
120 capsules this page64896-0968-23 No Medicaid data
Drug total (last 4 qtrs): 431 Rx · 66,491 units · $289,413 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 Crexont — 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 Crexont. 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
$23.05M
Claims incl. refills
30K
Beneficiaries
14.1K
Spend / beneficiary
$1,632.00
Spend / claim
$768.39
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
64896-0968-16 1 BOTTLE in 1 CARTON (64896-968-16) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE $4.58 / ea $549.89 2024-08-09 Active
64896-0968-23 You're viewing this 1 BOTTLE in 1 CARTON (64896-968-23) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE — — 2024-08-09 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 64896-0968-23?
NDC 64896-0968-23 is a 120-count package — 1 bottle in 1 carton / 120 capsule, extended release in 1 bottle.
What is the difference between NDC 64896-0968-23 and NDC 64896-0968-16?
Both are CREXONT carbidopa and levodopa 52.5 mg; 210 mg Capsule, Extended Release — the drug itself is identical. NDC 64896-0968-23 is the 120-count package, while NDC 64896-0968-16 is the 120 capsules package.
What NDC number is used to bill for this package of CREXONT carbidopa and levodopa 52.5 mg; 210 mg Capsule, Extended Release?
Bill NDC 64896-0968-23 — the 11-digit billing format is 64896096823. 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 64896-968-23, 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: 64896-0968-23, written without dashes as 64896096823. 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 64896-0968-23, the first segment (64896) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0968) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (23) 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 1 other package presentation of this same product, including 120 capsules (64896-0968-16). 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?
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📄 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 📋 Description 💬 Information for Patients
🎯 Indications and Usage 71 words ▾

1 INDICATIONS AND USAGE CREXONT is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults. CREXONT 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 in adults.

( 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 35 mg carbidopa / 140 mg levodopa taken orally twice daily for the first 3 days; on the fourth day of treatment, dosage may be increased gradually as needed. ( 2.2 ) Patients converting from immediate-release carbidopa/levodopa: See Table 1 for instructions; dosages are not substitutable on a 1:1 basis.

( 2.3 ) The maximum recommended daily dosage of CREXONT is 525 mg carbidopa / 2100 mg levodopa. ( 2.2 , 2.3 ) CREXONT may be taken with or without food; do not chew, divide, or crush. ( 2.5 , 12.3 ) CREXONT should not be taken with alcohol.

( 2.5 , 12.3 )

2.1Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating carbidopa/levodopa therapies, including CREXONT, 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 CREXONT while supplementing vitamin B6.

2.2Dosage in Patients Naïve to Levodopa Therapy The recommended starting dosage of CREXONT in levodopa-naïve patients is 35 mg carbidopa / 140 mg levodopa taken orally twice daily for the first three days. Thereafter, dosage may be increased gradually as needed to a maximum daily dosage of 525 mg carbidopa / 2100 mg levodopa divided up to four times daily.

2.3Dosage in Patients Converting from Immediate-Release Carbidopa-Levodopa to CREXONT The dosages of immediate-release carbidopa-levodopa products are not substitutable on a 1:1 basis with the dosages of CREXONT. To convert patients from immediate-release carbidopa-levodopa to CREXONT, follow these steps: Step 1: Determine the patient’s total daily dosage of immediate-release levodopa. Step 2: Determine the patient’s most frequent single dose of immediate-release levodopa.

If more than one dose corresponds to the most frequent, use the highest of the doses. Step 3: Find the values from Step 1 and Step 2 in Table 1 (below) to determine the recommended starting CREXONT dosage of levodopa and dosing frequency. Step 4: After one to three days, adjust the dose or frequency as needed based on the patient’s clinical response and tolerability.

Dosage may be increased gradually as needed to a maximum daily dosage of 525 mg carbidopa / 2100 mg levodopa divided up to four times daily. Table 1: Conversion from Immediate-Release Carbidopa-Levodopa to CREXONT Total Daily Immediate-Release Levodopa Dosage Most Frequent Immediate-Release Levodopa Single Dose Recommended Starting CREXONT Dosage of Levodopa Less than 500 mg daily 100 mg 280 mg twice daily 150 mg 420 mg twice daily 200 mg 560 mg twice daily Equal to or greater than 500 mg daily 100 mg 280 mg three times daily 150 mg 420 mg three times daily 200 mg 560 mg three times daily Greater than 200 mg 700 mg three times daily For patients currently treated with carbidopa and levodopa plus a catechol-O-methyl transferase (COMT) inhibitor (e.g., entacapone or opicapone), the initial total daily dose of levodopa in CREXONT may need to be increased if the COMT inhibitor is discontinued.

Use of CREXONT in combination with other levodopa products has not been studied.

2.4Dosage for Patients Converting from Extended-Release Carbidopa-Levodopa (Rytary) to CREXONT For patients converting from RYTARY (extended-release carbidopa-levodopa), initiate CREXONT on an approximately 1:1 mg basis using the levodopa component for conversion.

2.5Administration Information Swallow CREXONT whole with or without food. CREXONT should not be taken with alcohol. A high-fat, high-calorie meal may delay the absorption of levodopa to reach the peak plasma concentration by about 2 hours [see Clinical Pharmacology (12.3) ]. Do not chew, divide, or crush CREXONT capsules. For patients who have difficulty swallowing intact capsules, administer CREXONT by…

💊 Dosage Forms and Strengths 176 words ▾

3 DOSAGE FORMS AND STRENGTHS CREXONT extended-release capsules contain white to off-white granules and pellets and are available in the following strengths: 35 mg carbidopa and 140 mg levodopa: Capsules with white opaque body and yellow opaque cap. Body imprinted with “140” in black ink and cap imprinted with “IPX203” in white ink. 52.5 mg carbidopa and 210 mg levodopa: Capsules with white opaque body and green opaque cap.

Body imprinted with “210” in black ink and cap imprinted with “IPX203” in white ink. 70 mg carbidopa and 280 mg levodopa: Capsules with white opaque body and purple opaque cap. Body imprinted with “280” in black ink and cap imprinted with “IPX203” in white ink.

87.5mg carbidopa and 350 mg levodopa: Capsules with white opaque body and medium orange opaque cap. Body imprinted with “350” in black ink and cap imprinted with “IPX203” in white ink. Extended-Release Capsules: Carbidopa and Levodopa 35 mg / 140 mg, 52.5 mg / 210 mg, 70 mg / 280 mg, 87.

5 mg / 350 mg ( 3 )

⛔ Contraindications 45 words ▾

4 CONTRAINDICATIONS CREXONT is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor 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 CREXONT 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 CREXONT, 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, such as excessive drowsiness, and believed that they were alert immediately prior to the event (sleep attack). Some of these events have been reported more than 1 year after initiation of treatment.

Falling asleep while engaged in activities of daily living usually occurs in patients experiencing preexisting somnolence, although patients may not give such a history. For this reason, prescribers should reassess for drowsiness or sleepiness in CREXONT-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 CREXONT, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with CREXONT, such as concomitant sedating medications or the presence of a sleep disorder. Consider discontinuing CREXONT 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 CREXONT, 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 CREXONT. If the decision is made to discontinue CREXONT, the dose should be tapered to reduce the risk of hyperpyrexia and confusion [see Dosage and Administration (2.6) ] .

5.3Cardiovascular Ischemic Events Cardiovascular ischemic events have occurred in patients taking CREXONT. In Study 1 [see Clinical Studies (14) ], 4/589 (0.7%) of CREXONT-treated patients experienced cardiovascular ischemic adverse reactions compared to 2/630 (0.3%) of 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 period of initial dosage adjustment.

5.4Hallucinations/Psychosis There is an increased risk for hallucinations in patients taking CREXONT. In Study 1, 17/589 (3%) of CREXONT-treated patients reported hallucinations compared to 2/630 (0.3%) of oral immediate-release carbidopa-levo…

🤒 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/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) ] P eptic Ulcer Disease [see Warnings and Precautions (5.8) ] Glaucoma [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence ≥ 3% and greater than immediate-release CD-LD) are nausea and anxiety.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals 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 589 patients with Parkinson’s disease who received CREXONT for up to 76 weeks and had an average duration of exposure of 35 weeks. Study 1 in patients with Parkinson’s Disease consisted of a dose adjustment period of immediate-release carbidopa-levodopa treatment prior to a 4-week dose conversion period to CREXONT, which was then followed by a 13-week, double-blind, randomized period comparing CREXONT to immediate-release carbidopa-levodopa [see Clinical Studies (14) ].

In Study 1 , the most common adverse reactions (in at least 3% of patients treated with CREXONT and more frequently than with immediate-release carbidopa-levodopa) that occurred during the double-blind maintenance period were nausea and anxiety. Table 2 lists adverse reactions occurring in at least 2% of CREXONT-treated patients while converting from immediate-release carbidopa-levodopa and at a higher rate than immediate-release carbidopa-levodopa in the double-blind maintenance period. Table 2.

Adverse Reactions that Occurred in at Least 2% of Patients with Parkinson’s Disease who Received CREXONT and at a Higher Rate than Patients who Received Immediate-Release Carbidopa-Levodopa (Study 1) Adverse Reaction Dose Conversion Period Double-Blind Period CREXONT CREXONT Immediate-Release Carbidopa-Levodopa (N=589) % (N=256) % (N= 250) % Nausea 5 4 1 Anxiety 2 3 0 Dizziness 3 2 1 Dyskinesia 7 2

0.4 Constipation 2 2

0.4 Headache 2 1 0 Vomiting 2 1 0 Insomnia 2 1

0.4Adverse Reactions Leading to Discontinuation In Study 1, 6% of patients discontinued treatment because of adverse reactions during conversion to CREXONT. During the double-blind treatment period of Study 1, 5% of patients taking CREXONT and 1% of patients taking immediate-release carbidopa-levodopa discontinued treatment because of adverse events. The common adverse reactions leading to drug discontinuation during dose conversion were dyskinesia, dizziness, and nausea.

🔄 Drug Interactions 168 words ▾

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

7.1Monoamine Oxidase (MAO) Inhibitors Nonselective MAO Inhibitors The use of nonselective MAO inhibitors (e.g., phenelzine and tranylcypromine) with CREXONT is contraindicated [see Contraindications (4) ] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating CREXONT. Selective MAO Inhibitors The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with CREXONT 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 CREXONT. If iron salts or multivitamins containing iron salts are co-administered with CREXONT, monitor patients for worsening Parkinson’s symptoms.

👥 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 CREXONT (carbidopa and levodopa) 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 CREXONT is a combination of carbidopa and levodopa. Carbidopa There are no adequate data on the presence of carbidopa in human milk, the effects on the breastfed infant, or the effects on milk production. Carbidopa is excreted in rat milk.

Levodopa Levodopa has been detected in human milk after administration of carbidopa-levodopa. Levodopa decreases secretion of prolactin in humans, which may inhibit lactation. There are no adequate data on the effects of levodopa on the breastfed infant.

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

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

8.5Geriatric Use There were 282 (45%) patients 65 to less than 74 years of age and 112 (18%) patients 75 years of age and older treated with CREXONT in an active-controlled study for Parkinson’s disease (Study 1) [see Clinical Studies (14) ] . There were no differences in safety outcomes between patients less than 65 years of age, 65 to less than 75 years of age, or 75 years and older.

🤰 Pregnancy 148 words ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of CREXONT (carbidopa and levodopa) 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 72 words ▾

8.5Geriatric Use There were 282 (45%) patients 65 to less than 74 years of age and 112 (18%) patients 75 years of age and older treated with CREXONT in an active-controlled study for Parkinson’s disease (Study 1) [see Clinical Studies (14) ] . There were no differences in safety outcomes between patients less than 65 years of age, 65 to less than 75 years of age, or 75 years and older.

🆘 Overdosage 129 words ▾

10 OVERDOSAGE Based on the limited available information, the acute symptoms of levodopa/carbidopa 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.

In the event of CREXONT overdosage, 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. 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.

Cardiac Electrophysiology At exposures corresponding to the maximum recommended dose of carbidopa in CREXONT, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics The pharmacokinetics of CREXONT were evaluated following single doses in healthy subjects and following single and multiple doses in patients with Parkinson’s disease. CREXONT shows dose proportional pharmacokinetics for both carbidopa and levodopa over the carbidopa/levodopa dosage strength range of 35 mg/140 mg to 87.5 mg/350 mg. Absorption Carbidopa Following oral dosing of CREXONT, the maximum concentration occurred at approximately 2.5 hours.

The bioavailability of carbidopa from CREXONT relative to immediate-release carbidopa-levodopa tablets was approximately 103% to 123%. Levodopa The bioavailability of levodopa from CREXONT was approximately 88% to 99% relative to immediate-release carbidopa-levodopa. For comparable doses, CREXONT results in a levodopa peak concentration (C max ) that is 38% that of immediate-release carbidopa-levodopa.

Following an initial peak at about one hour, plasma concentrations were maintained for about 6 to 7 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 1.7 for CREXONT compared to approximately 2.7 for immediate-release carbidopa-levodopa.

Effect of Food Carbidopa In healthy adults, oral administration of CREXONT following a high-fat, high-calorie meal decreased carbidopa C max and AUC by approximately 64% and delayed carbidopa T max by approximately one hour compared to administration in the fasted state. Oral administration of CREXONT by sprinkling the capsule contents on applesauce decreased carbidopa C max and AUC by approximately 13% and 9%, respectively, compared to the intact capsule administered in the fasted state [see Dosage and Administration (2.5) ] .

Levodopa In healthy adults, oral administration of CREXONT following a high-fat, high-calorie meal increased levodopa C max and AUC by approximately 19% and 18%,, respectively, and delayed levodopa T max by approximately two hours compared to administration in the fasted state [see Dosage and Administration (2.5) ] . High protein meals may decrease the absorption of levodopa. Oral administration of CREXONT by sprinkling the capsule contents on applesauce did not significantly affect levodopa concentration time profiles compared to the intact capsule administered in the fasted state.

Distribution Approximately 36% of carbidopa binds to plasma proteins. Approximately…

🧬 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 treats symptoms of Parkinson's disease.

📦 How Supplied / Storage and Handling 205 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied CREXONT capsules contain white to off-white granules and pellets and are available in bottles of 120 capsules as follows: Capsule Strength Description NDC Number 35 mg Carbidopa and 140 mg Levodopa Capsules with white opaque body and yellow opaque cap. Body imprinted with “140” in black ink and cap imprinted with “IPX203” in white ink. 64896-967-16 52.5 mg Carbidopa and 210 mg Levodopa Capsules with white opaque body and green opaque cap.

Body imprinted with “210” in black ink and cap imprinted with “IPX203” in white ink. 64896-968-16 70 mg Carbidopa and 280 mg Levodopa Capsules with white opaque body and purple opaque cap. Body imprinted with “280” in black ink and cap imprinted with “IPX203” in white ink.

64896-969-16 87.5 mg Carbidopa and 350 mg Levodopa Capsules with white opaque body and medium orange opaque cap. Body imprinted with “350” in black ink and cap imprinted with “IPX203” in white ink. 64896-970-16

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 CREXONT 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. CREXONT contains immediate-release granules consisting of carbidopa and levodopa and extended-release pellets consisting of levodopa. Carbidopa is a white to off-white powder, crystalline compound, slightly soluble in water, with a molecular weight of 244.24.

It is designated chemically as (–)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxy-benzene) propanoic 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 226.3. 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-dihydroxy-benzene) propanoic acid. Its molecular formula is C 9 H 11 NO 4 and its structural formula is: Each CREXONT extended-release capsule contains 35 mg carbidopa and 140 mg levodopa, 52.5 mg carbidopa and 210 mg levodopa, 70 mg carbidopa and 280 mg levodopa, or 87.5 mg carbidopa and 350 mg levodopa. The inactive ingredients are amino methacrylate copolymer, cellulose acetate, copovidone, croscarmellose sodium, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, povidone, sodium lauryl sulfate, talc, and triethyl citrate.

The 35mg/140 mg capsule shell contains D&C yellow #10, gelatin, Red Iron Oxide, and titanium dioxide. The 52.5 mg/210 mg capsule shell contains FD&C Blue #1, gelatin, titanium dioxide, and yellow iron oxide. The 70 mg/280 mg capsule shell contains FD&C Blue #1, FD&C Red #3, gelatin, and titanium dioxide.

The 87.5 mg/350 mg capsule shell contains gelatin, Red Iron Oxide, titanium dioxide, and yellow iron oxide. The black imprinting ink contains ammonium hydroxide, ethanol, ferrosoferric oxide/black iron oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze. The white imprinting ink contains ethanol, isopropyl alcohol, n-butyl alcohol, povidone, propylene glycol, shellac glaze, sodium hydroxide, and titanium dioxide.

CD Structural Formula LD Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Dosing Instructions Advise patients not to take other carbidopa-levodopa preparations with CREXONT without consulting their healthcare provider [see Dosage and Administration (2.2) ] . Advise patients to swallow CREXONT whole, without chewing, dividing, or crushing [see Dosage and Administration (2.5) ] . For patients with difficulty swallowing, inform them that the entire contents of CREXONT may be sprinkled on 1 to 2 tablespoons of applesauce and should be swallowed immediately without chewing [see Dosage and Administration (2.4) ] .

Instruct patients that CREXONT should not be taken with alcohol [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ]. Inform patients that a high fat, high calorie meal may delay the absorption of levodopa and the onset of action by 2 to 5 hours. For this reason, consideration should be given to taking the first dose of the day about 1 to 2 hours before eating.

The patient should also 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 [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ]. Advise patients to call their healthcare provider before stopping CREXONT. Discontinue CREXONT 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 (2.6) and Warnings and Precautions (5.2) ] . Falling Asleep During Activities of Daily Living and Somnolence Advise patients that certain side effects such as sleepiness and dizziness that have been reported with CREXONT may affect some patients’ ability to drive and operate machinery safely [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .

Suicidal Ideation and Suicidal Behavior Instruct patients, family members and caregivers to notify their healthcare provider if suicidal ideation and/or suicidal behavior are experienced by patients using CREXONT [see Warnings and Precautions (5.2) ] . 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 CREXONT [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 CREXONT. 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 CNS depressants in combination with CREXONT.

Pregnancy and Breastfeeding Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during carbidopa and levodopa extended-release capsule therapy [see Use in Specific Populations (8.1) ] . Instruct patients to notify their physicians if they intend to breast-feed or are breast-feeding an infant [see Use in Specific Populations (8.2) ] .…

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