Carbidopa and levodopa 50 mg; 200 mg Tablet, Extended Release, 1,000-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Aromatic Amino Acid Decarboxylation Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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?
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🧪 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.
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UNII 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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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.
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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.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
7 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 system | Per each | Per 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Carbidopa and Levodopa 50 mg/1; 200 mg 00378-0094-01 | Mylan | 100 tablets | $0.173 | AB | Availability likely | — |
| Carbidopa And Levodopa 50 mg/1; 200 mg 16729-0079-01 | Accord | 100 tablets | $0.173 | AB | Availability likely | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 50228-0461-01 | ScieGen | 100 tablets | $0.173 | AB | Availability likely | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 51079-0923-20 | Mylan | 1 tablet | $0.173 | AB | Availability likely | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 60219-2034-01 | Amneal | 100 tablets | $0.173 | AB | Availability likely | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 00615-8461-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 46708-0333-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 48433-0016-20 | Safecor | 1 tablet | — | AB | FDA listed | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 62332-0333-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Carbidopa And Levodopa 50 mg/1; 200 mg 62756-0457-08 | Sun | 100 tablets | — | — | FDA listed | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 72162-2193-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Carbidopa and levodopa 50 mg/1; 200 mgthis 72888-0156-00 | Advagen | 1000 tablets | — | AB | FDA listed | — |
| Carbidopa and Levodopa 50 mg/1; 200 mg 77771-0461-01 | Radha | 100 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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💊 Medicaid utilization by pack size
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 72888-0156-00 You're viewing this | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-156-00) | — | — | 2024-06-04 | Active |
| 72888-0156-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-156-01) | $0.1735 / ea | $17.35 | 2024-06-04 | Active |
| 72888-0156-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-156-05) | — | — | 2024-06-04 | Active |
| 72888-0156-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-156-30) | $0.1735 / ea | $5.20 | 2024-06-04 | Active |
You're viewing the largest of 4 pack sizes for this product.
This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 72888-0156-00?
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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.
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| 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. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Carbidopa and levodopa extended-release tablet contains carbidopa and levodopa in a 1:4 ratio as either the 50 mg/200 mg tablet or the 25 mg/100 mg tablet. The daily dosage of carbidopa and levodopa extended-release tablets must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of involuntary movements, dyskinesias or nausea.
Carbidopa and levodopa extended-release tablets should not be chewed or crushed. Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa extended-release tablet is being administered, although their dosage may have to be adjusted. Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, carbidopa and levodopa extended-release tablets can be given to patients receiving supplemental pyridoxine (vitamin B 6 ).
Management of Vitamin B 6 Levels Evaluate vitamin B 6 levels prior to initiating carbidopa/levodopa therapies including carbidopa and levodopa extended-release tablets, periodically during treatment, and as clinically indicated (see WARNINGS, Vitamin B6 Deficiency and Seizures ). If vitamin B 6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with carbidopa and levodopa extended-release tablets while supplementing vitamin B 6 .
Initial Dosage Patients currently treated with conventional carbidopa levodopa preparations: Studies show that peripheral dopa-decarboxylase is saturated by the bioavailable carbidopa at doses of 70 mg a day and greater. Because the bioavailabilities of carbidopa and levodopa in carbidopa and levodopa tablets and carbidopa and levodopa extended-release tablets are different, appropriate adjustments should be made, as shown in Table 2. Table 2: Approximate Bioavailabilities at Steady State* Tablet Amount of Levodopa (mg) in Each Tablet Approximate Bioavailability Approximate Amount of Bioavailable Levodopa (mg) in Each Tablet Carbidopa and levodopa extended-release tablets 50 mg/ 200 mg 200 0.70-0.75 † 140-150 Carbidopa and levodopa tablets 25 mg/ 100 mg 100 0.99 ‡ 99 * This table is only a guide to bioavailabilities since other factors such as food, drugs, and inter-patient variabilities may affect the bioavailability of carbidopa and levodopa. † The extent of availability of levodopa from carbidopa and levodopa extended-release tablets was about 70-75% relative to intravenous levodopa or standard carbidopa and levodopa tablets in the elderly. ‡ The extent of availability of levodopa from carbidopa and levodopa tablets was 99% relative to intravenous levodopa in the healthy elderly.
Dosage with carbidopa and levodopa extended-release tablets should be substituted at an amount that provides approximately 10% more levodopa per day, although this may need to be increased to a dosage that provides up to 30% more levodopa per day depending on clinical response (see DOSAGE AND ADMINISTRATION, Titration with carbidopa and levodopa extended-release tablets ). The interval between doses of carbidopa and levodopa extended-release tablets should be 4-8 hours during the waking day. (See CLINICAL PHARMACOLOGY, Pharmacodynamics. ) A guideline for initiation of carbidopa and levodopa extended-release tablets is shown in Table 3.
Table 3: Guidelines for Initial Conversion from Carbidopa and Levodopa Tablets to Carbidopa and Levodopa Extended-Release Tablets Carbidopa and levodopa tablets Carbidopa and levodopa extended-release tablets Total Daily Dose* Suggested Levodopa (mg) Dosage Regimen 300-400 200 mg b.i.d. 500-600 300 mg b.i.d. or 200 mg t.i.d. 700-800 A total of 800 mg in 3 or more divided doses (e.g., 300 mg a.m., 300 mg early p.m., and 200 mg later p.m.) 900-1000 A total of 1000 mg in 3 or more divided doses (e.g., 400 mg a.m., 400 mg early p.m., and 200 mg later p.m.) *Fo…
⛔ Contraindications ▾
CONTRAINDICATIONS Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa extended-release tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa extended-release tablets. Carbidopa and levodopa extended-release tablets may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (see PRECAUTIONS, Drug Interactions ). carbidopa and levodopa extended-release tablets are contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.
⚠️ Warnings ▾
WARNINGS When patients are receiving levodopa without a decarboxylase inhibitor, levodopa must be discontinued at least twelve hours before carbidopa and levodopa extended-release tablets are started. In order to reduce adverse reactions, it is necessary to individualize therapy. See DOSAGE AND ADMINISTRATION section before initiating therapy.
Carbidopa and levodopa extended-release tablets should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage (see DOSAGE AND ADMINISTRATION ). Carbidopa does not decrease adverse reactions due to central effects of levodopa. By permitting more levodopa to reach the brain, particularly when nausea and vomiting is not a dose-limiting factor, certain adverse central nervous system (CNS) effects, e.g., dyskinesias, will occur at lower dosages and sooner during therapy with carbidopa and levodopa extended-release tablets than with levodopa alone.
Patients receiving carbidopa and levodopa extended-release tablets may develop increased dyskinesias compared to carbidopa and levodopa tablets. Dyskinesias are a common side effect of carbidopa levodopa treatment. The occurrence of dyskinesias may require dosage reduction.
All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Carbidopa and levodopa extended-release tablets should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease. As with levodopa, care should be exercised in administering carbidopa and levodopa extended-release tablets to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias.
In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care. As with levodopa, treatment with carbidopa and levodopa extended-release tablets may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer. Vitamin B 6 Deficiency and Seizures Treatment with carbidopa and levodopa extended-release tablets may contribute to reduced vitamin B 6 levels.
Higher doses of carbidopa/levodopa may increase the risk of vitamin B 6 deficiency. Seizures associated with vitamin B 6 deficiency have been reported in the postmarketing setting in patients taking carbidopa and levodopa extended-release tablets. In these reported cases, seizures were refractory to traditional anti-seizure medications and only resolved after vitamin B 6 administration.
Other symptoms of vitamin B 6 deficiency may occur, including depression, confusion, cheilosis, glossitis, dermatitis, anemia, and/or neuropathy. Evaluate vitamin B 6 levels prior to initiation of carbidopa and levodopa extended-release tablets and periodically while on treatment or if symptoms associated with vitamin B 6 deficiency are identified. Supplement with vitamin B 6 as necessary.
Falling Asleep During Activities of Daily Living and Somnolence Patients taking carbidopa and levodopa extended-release tablets alone or with other dopaminergic drugs have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living (includes operation of motor vehicles). Road traffic accidents attributed to sudden sleep onset have been reported. Although many patients reported somnolence while on dopaminergic medications, there have been reports of road traffic accidents attributed to sudden onset of sleep in which the patient did not perceive any warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event.
Sudden onset of sleep has been reported to occur as long as one year after the initiation of treatment. Falling asleep while engaged in activities of daily living usually occurs in patients experiencing pre- existing somnolence, although…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials, patients predominantly with moderate to severe motor fluctuations while on carbidopa and levodopa tablets were randomized to therapy with either carbidopa and levodopa tablets or carbidopa and levodopa extended-release tablets. The adverse experience frequency profile of carbidopa and levodopa extended-release tablets did not differ substantially from that of carbidopa and levodopa extended-release tablets, as shown in Table 1. Table 1: Clinical Adverse Experiences Occurring in 1% or Greater of Patients Carbidopa and levodopa extended-release tablets Carbidopa and levodopa tablets n=491 n=524 Adverse Experience % % Dyskinesia 16.5
12.2Nausea 5.5
5.7Hallucinations 3.9
3.2Confusion 3.7
2.3Dizziness 2.9
2.3Depression 2.2
1.3Urinary tract infection 2.2
2.3Headache 2.0
1.9Dream abnormalities 1.8
0.8Dystonia 1.8
0.8Vomiting 1.8
1.9Upper respiratory infection 1.8
1.0Dyspnea 1.6 0.4 ‘On-Off’ phenomena 1.6
1.1Back pain 1.6
0.6Dry mouth 1.4
1.1Anorexia 1.2
1.1Diarrhea 1.2
0.6Insomnia 1.2
1.0Orthostatic hypotension 1.0
1.1Shoulder pain 1.0
0.6Chest pain 1.0
0.8Muscle cramps 0.8
1.0Paresthesia 0.8
1.1Urinary frequency 0.8
1.1Dyspepsia 0.6
1.1Constipation 0.2
1.5Abnormal laboratory findings occurring at a frequency of 1% or greater in approximately 443 patients who received carbidopa and levodopa extended-release tablets and 475 who received carbidopa and levodopa tablets during controlled clinical trials included: decreased hemoglobin and hematocrit; elevated serum glucose; white blood cells, bacteria and blood in the urine. The adverse experiences observed in patients in uncontrolled studies were similar to those seen in controlled clinical studies. Other adverse experiences reported overall in clinical trials in 748 patients treated with carbidopa and levodopa extended-release tablets, listed by body system in order of decreasing frequency, include: Body as a Whole Asthenia, fatigue, abdominal pain, orthostatic effects.
Cardiovascular Palpitation, hypertension, hypotension, myocardial infarction. Gastrointestinal Gastrointestinal pain, dysphagia, heartburn. Metabolic Weight loss.
Musculoskeletal Leg pain. Nervous System/Psychiatric Chorea, somnolence, falling, anxiety, disorientation, decreased mental acuity, gait abnormalities, extrapyramidal disorder, agitation, nervousness, sleep disorders, memory impairment. Respiratory Cough, pharyngeal pain, common cold.
Skin Rash. Special Senses Blurred vision. Urogenital Urinary incontinence.
Laboratory Tests Decreased white blood cell count and serum potassium; increased BUN, serum creatinine and serum LDH; protein and glucose in the urine. The following adverse experiences have been reported in postmarketing experience with carbidopa and levodopa extended-release tablets: Cardiovascular Cardiac irregularities, syncope. Gastrointestinal Taste alterations, dark saliva.
Hypersensitivity Angioedema, urticaria, pruritus, bullous lesions (including pemphigus-like reactions). Nervous System/Psychiatric Increased tremor, peripheral neuropathy, psychotic episodes including delusions and paranoid ideation, pathological gambling, increased libido including hypersexuality, impulse control symptoms. Skin Alopecia, flushing, dark sweat.
Urogenital Dark urine. Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulations and may occur with carbidopa and levodopa extended-release tablets are: Cardiovascular Phlebitis. Gastrointestinal Gastrointestinal bleeding, development of duodenal ulcer, sialorrhea, bruxism, hiccups, flatulence, burning sensation of tongue.
Hematologic Hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia, agranulocytosis. Hypersensitivity Henoch-Schönlein purpura. Metabolic Weight gain, edema.
Nervous System/Psychiatric Ataxia, depression with suicidal tendencies, dementia, euphoria, bradykinetic episodes, numbness, muscle twitching, blepharospasm (…
🆘 Overdosage ▾
OVERDOSAGE Management of acute overdosage with carbidopa and levodopa extended-release tablets is the same as with levodopa. Pyridoxine is not effective in reversing the actions of carbidopa and levodopa extended-release tablets. General supportive measures should be employed, along with immediate gastric lavage.
Intravenous fluids should be administered judiciously and an adequate airway maintained. Electrocardiographic monitoring should be instituted and the patient carefully observed for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as carbidopa and levodopa extended-release tablets should be taken into consideration.
To date, no experience has been reported with dialysis; hence, its value in overdosage is not known. Based on studies in which high doses of levodopa and/or carbidopa were administered, a significant proportion of rats and mice given single oral doses of levodopa of approximately 1500-2000 mg/kg are expected to die. A significant proportion of infant rats of both sexes are expected to die at a dose of 800 mg/kg.
A significant proportion of rats are expected to die after treatment with similar doses of carbidopa. The addition of carbidopa in a 1:10 ratio with levodopa increases the dose at which a significant proportion of mice are expected to die to 3360 mg/kg.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Parkinson's disease is a progressive, neurodegenerative disorder of the extrapyramidal nervous system affecting the mobility and control of the skeletal muscular system. Its characteristic features include resting tremor, rigidity, and bradykinetic movements. Symptomatic treatments, such as levodopa therapies, may permit the patient better mobility.
Current evidence indicates that symptoms of Parkinson's disease are related to depletion of dopamine in the corpus striatum. Administration of dopamine is ineffective in the treatment of Parkinson's disease apparently because it does not cross the blood-brain barrier. However, levodopa, the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain.
This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson's disease. Pharmacodynamics 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. For this reason, large doses of levodopa are required for adequate therapeutic effect, and these may often be accompanied by nausea and other adverse reactions, some of which are attributable to dopamine formed in extracerebral tissues.
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. Carbidopa inhibits decarboxylation of peripheral levodopa. It does not cross the blood-brain barrier and does not affect the metabolism of levodopa within the central nervous system.
Since its decarboxylase inhibiting activity is limited to extracerebral tissues, administration of carbidopa with levodopa makes more levodopa available for transport to the brain. Patients treated with levodopa therapy for Parkinson's disease may develop motor fluctuations characterized by end-of-dose failure, peak dose dyskinesia, and akinesia. The advanced form of motor fluctuations (‘on-off’ phenomenon) is characterized by unpredictable swings from mobility to immobility.
Although the causes of the motor fluctuations are not completely understood, in some patients they may be attenuated by treatment regimens that produce steady plasma levels of levodopa. Carbidopa and levodopa extended-release tablets contains either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa in an extended-release dosage form designed to release these ingredients over a 4-to 6-hour period. With carbidopa and levodopa extended-release tablets there is less variation in plasma levodopa levels than with carbidopa and levodopa immediate release tablets, the conventional formulation.
However, carbidopa and levodopa extended-release tablets are less systemically bioavailable than carbidopa and levodopa tablets and may require increased daily doses to achieve the same level of symptomatic relief as provided by carbidopa and levodopa tablets. In clinical trials, patients with moderate to severe motor fluctuations who received carbidopa and levodopa extended-release tablets did not experience quantitatively significant reductions in ‘off’ time when compared to carbidopa and levodopa tablets. However, global ratings of improvement as assessed by both patient and physician were better during therapy with carbidopa and levodopa extended-release tablets than with carbidopa and levodopa tablets.
In patients without motor fluctuations, carbidopa and levodopa extended-release tablets, under controlled conditions, provided the same therapeutic benefit with less frequent dosing when compared to carbidopa and levodopa tablets. Pharmacokinetics Carbidopa reduces the amount of levodopa required to produce a given response by about 75% and, when administered with levodopa, increases both plasma levels and the plasma half-life of levodopa, and decreases…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Carbidopa and levodopa extended-release tablets, USP 25 mg/100 mg are light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ50” on one side and plain on other. They are supplied as follows: NDC 72888-155-30, bottles of 30. NDC 72888-155-01, bottles of 100.
NDC 72888-155-05, bottles of 500. NDC 72888-155-00, bottles of 1000. Carbidopa and levodopa extended-release tablets, USP 50 mg/200 mg are light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ51” on one side and plain on other.
They are supplied as follows: NDC 72888-156-30, bottles of 30. NDC 72888-156-01, bottles of 100. NDC 72888-156-05, bottles of 500.
NDC 72888-156-00, bottles of 1000. Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° 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. All trademarks are the property of their respective owners. Manufactured by: Rubicon Research Limited Thane 421506, India Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA Revision: 04/2026
📋 Description ▾
DESCRIPTION Carbidopa and levodopa extended-release tablets, USP are extended-release oral dosage form and are combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, 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-dihydroxybenzene) propanoic acid monohydrate.
Its empirical 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, an aromatic amino acid, 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.
Its empirical formula is C 9 H 11 NO 4 , and its structural formula is: Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Carbidopa and levodopa extended-release tablets, USP 25 mg/100 mg and 50 mg/ 200 mg also contain FD&C red 40 Alu lake and FD&C blue 2 Alu lake.
The 25 mg/100 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ50” on one side and plain on other. The 50 mg/200 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ51” on one side and plain on other. The carbidopa and levodopa extended-release tablets are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes.
Carbidopa and levodopa extended-release tablets 25 mg/100 mg are available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP. image description image description