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Metyrosine 250 mg Capsule, 100-count — NDC 75907-0166-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metyrosine 250 mg Capsule, 100-count — NDC 75907-166-01 (Billing 75907-0166-01)

by Dr. Reddy's Laboratories Inc. · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Metyrosine 250 mg Capsule from Dr. Reddy's Laboratories Inc., marketed since May 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 75907-0166-01
🏷️ FDA NDC (as labeled) 75907-166-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $236.16/unit — full pricing hub ↓
Main listing for product 75907-166 · Also comes in: 30 capsules 75907-166-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 75907-166-01
Product NDC 75907-166
11-digit billing NDC 75907016601
NCPDP billing unit EA — each (per item)
RxCUI 197980
UNII DOQ0J0TPF7
UPC 0375907166303
Application # ANDA218620
SPL Set ID 1b7897b4-7681-4b99-8883-d5dc33f86c01
Established class (EPC) Catecholamine Synthesis Inhibitor
Mechanism of action Catecholamine Synthesis Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-30
Route ORAL
Dosage form CAPSULE
Substance METYROSINE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 36300025000110
GCN Seq No 000400
GCN 01540
HICL code 000138
Ingredient (HICL) Metyrosine
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4Y
Therapeutic class — specific (HIC3) Antihypertensives, Miscellaneous
AHFS code 36:64.00.00
AHFS class Pheochromocytoma
FDB label name METYROSINE 250 MG CAPSULE
FDB brand name Metyrosine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000400
  • GCN: 01540
  • GPI-14 (Medi-Span): 36300025000110
  • HICL (First Databank): 000138
  • AHFS class code: 36:64.00.00
  • RxCUI (RxNorm): 197980
Why two NDCs? The FDA registers this code as 75907-166-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 75907-0166-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Catecholamine Synthesis Inhibitor class.

Pharmacologic class Catecholamine Synthesis Inhibitor
Drug family (ATC) Tyrosine hydroxylase inhibitors
How it works Catecholamine Synthesis Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name METYROSINE 250 MG CAPSULE Ingredient Metyrosine

Supplement & herbal interactions

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

Pricing

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

Price systemPer 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 $236.16 $23,615.78 / 100 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
75907-0166-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2025-05-30 — Active
75907-0166-30 75907-166-30 30 CAPSULE in 1 BOTTLE 2025-05-30 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 75907-0166-30?
Both are Metyrosine 250 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 75907-0166-30 is the 30 capsules package.
What NDC number is used to bill for this package of Metyrosine 250 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Demser 250 mg 25010-0305-15 Bausch 100 capsules — AB FDA listed —
Metyrosine 250 mg 68682-0310-01 Oceanside 100 capsules — AB FDA listed —
metyrosine 250 mg 69238-1621-01 Amneal 100 capsules — AB FDA listed —
Metyrosine 250 mgthis 75907-0166-01 Dr. 100 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Blue
ShapeCapsule
Imprint315;C
Size22 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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 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 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.
  • UNII 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • 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 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.
  • 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.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerDr. Reddy's Laboratories Inc.
Application holderDR REDDYS LABORATORIES SA
FDA applicationANDA218620 (ANDA)
Labeler code75907
First marketedMay 2025
Product typeHuman Prescription Drug
Portfolio160 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.

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

INDICATIONS AND USAGE Metyrosine capsules are indicated in the treatment of patients with pheochromocytoma for: Preoperative preparation of patients for surgery Management of patients when surgery is contraindicated Chronic treatment of patients with malignant pheochromocytoma Metyrosine capsules are not recommended for the control of essential hypertension.

⏱️ Dosage and Administration 183 words ▾

DOSAGE AND ADMINISTRATION The recommended initial dosage of metyrosine capsules for adults and children 12 years of age and older is 250 mg orally four times daily. This may be increased by 250 mg to 500 mg every day to a maximum of 4 g/day in divided doses. When used for preoperative preparation, the optimally effective dosage of metyrosine capsules should be given for at least five to seven days.

Optimally effective dosages of metyrosine usually are between 2 and 3 g/day, and the dose should be titrated by monitoring clinical symptoms and catecholamine excretion. In patients who are hypertensive, dosage should be titrated to achieve normalization of blood pressure and control of clinical symptoms. In patients who are usually normotensive, dosage should be titrated to the amount that will reduce urinary metanephrines and/or vanillylmandelic acid by 50% or more.

If patients are not adequately controlled by the use of metyrosine, an alpha-adrenergic blocking agent (phenoxybenzamine) should be added. Use of metyrosine in children under 12 years of age has been limited and a dosage schedule for this age group cannot be given.

⛔ Contraindications 14 words ▾

CONTRAINDICATIONS Metyrosine capsules are contraindicated in persons known to be hypersensitive to this compound.

⚠️ Warnings 182 words ▾

WARNINGS Maintain Fluid Volume During and After Surgery When metyrosine is used preoperatively, alone or especially in combination with alphaadrenergic blocking drugs, adequate intravascular volume must be maintained intraoperatively (especially after tumor removal) and postoperatively to avoid hypotension and decreased perfusion of vital organs resulting from vasodilatation and expanded volume capacity. Following tumor removal, large volumes of plasma may be needed to maintain blood pressure and central venous pressure within the normal range.

In addition, life-threatening arrhythmias may occur during anesthesia and surgery, and may require treatment with a beta-blocker or lidocaine. During surgery, patients should have continuous monitoring of blood pressure and electrocardiogram. Intraoperative Effects While the preoperative use of metyrosine capsules in patients with pheochromocytoma is thought to decrease intraoperative problems with blood pressure control, metyrosine does not eliminate the danger of hypertensive crises or arrhythmias during manipulation of the tumor, and the alpha-adrenergic blocking drug, phentolamine, may be needed.

Interaction with Alcohol Metyrosine may add to the sedative effects of alcohol and other CNS depressants, e.g., hypnotics, sedatives, and tranquilizers. (See PRECAUTIONS, Information for Patients and Drug Interactions .)

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Central Nervous System Sedation: The most common adverse reaction to metyrosine is moderate to severe sedation, which has been observed in almost all patients. It occurs at both low and high dosages. Sedative effects begin within the first 24 hours of therapy, are maximal after two to three days, and tend to wane during the next few days.

Sedation usually is not obvious after one week unless the dosage is increased, but at dosages greater than 2,000 mg/day some degree of sedation or fatigue may persist. In most patients who experience sedation, temporary changes in sleep pattern occur following withdrawal of the drug. Changes consist of insomnia that may last for two or three days and feelings of increased alertness and ambition.

Even patients who do not experience sedation while on metyrosine may report symptoms of psychic stimulation when the drug is discontinued. Extrapyramidal Signs: Extrapyramidal signs such as drooling, speech difficulty, and tremor have been reported in approximately 10% of patients. These occasionally have been accompanied by trismus and frank parkinsonism.

Anxiety and Psychic Disturbances: Anxiety and psychic disturbances such as depression, hallucinations, disorientation, and confusion may occur. These effects seem to be dose-dependent and may disappear with reduction of dosage. Diarrhea Diarrhea occurs in about 10% of patients and may be severe.

Anti-diarrheal agents may be required if continuation of metyrosine is necessary. Miscellaneous Infrequently, slight swelling of the breast, galactorrhea, nasal stuffiness, decreased salivation, dry mouth, headache, nausea, vomiting, abdominal pain, and impotence or failure of ejaculation may occur. Crystalluria (see PRECAUTIONS ) and transient dysuria and hematuria have been observed in a few patients.

Hematologic disorders (including eosinophilia, anemia, thrombocytopenia, and thrombocytosis), increased SGOT levels, peripheral edema, and hypersensitivity reactions such as urticaria and pharyngeal edema have been reported rarely. To report SUSPECTED ADVERSE REACTIONS, contact Cerovene, Inc. at 1-833-304-9569 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 57 words ▾

Drug Interactions Caution should be observed in administering metyrosine to patients receiving phenothiazines or haloperidol because the extrapyramidal effects of these drugs can be expected to be potentiated by inhibition of catecholamine synthesis. Concurrent use of metyrosine with alcohol or other CNS depressants can increase their sedative effects. (See WARNINGS and PRECAUTIONS , Information for Patients .)

🤰 Pregnancy 45 words ▾

Pregnancy Pregnancy: Animal reproduction studies have not been conducted with metyrosine. It is also not known whether metyrosine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Metyrosine should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

🧓 Geriatric Use 82 words ▾

Geriatric Use Clinical studies of metyrosine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 106 words ▾

OVERDOSAGE Signs of metyrosine overdosage include those central nervous system effects observed in some patients even at low dosages. At doses exceeding 2,000 mg/day, some degree of sedation or feeling of fatigue may persist. Doses of 2,000 to 4,000 mg/day can result in anxiety or agitated depression, neuromuscular effects (including fine tremor of the hands, gross tremor of the trunk, tightening of the jaw with trismus), diarrhea, and decreased salivation with dry mouth.

Reduction of drug dose or cessation of treatment results in the disappearance of these symptoms. The acute toxicity of metyrosine was 442 mg/kg and 752 mg/kg in the female mouse and rat, respectively.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Metyrosine inhibits tyrosine hydroxylase, which catalyzes the first transformation in catecholamine biosynthesis, i.e., the conversion of tyrosine to dihydroxyphenylalanine (DOPA). Because the first step is also the rate-limiting step, blockade of tyrosine hydroxylase activity results in decreased endogenous levels of catecholamines, usually measured as decreased urinary excretion of catecholamines and their metabolites. In patients with pheochromocytoma, who produce excessive amounts of norepinephrine and epinephrine, administration of 1 to 4 grams of metyrosine per day has reduced catecholamine biosynthesis from about 35% to 80% as measured by the total excretion of catecholamines and their metabolites (metanephrine and vanillylmandelic acid).

The maximum biochemical effect usually occurs within two to three days, and the urinary concentration of catecholamines and their metabolites usually returns to pretreatment levels within three to four days after metyrosine is discontinued. In some patients the total excretion of catecholamines and catecholamine metabolites may belowered to normal or near normal levels (less than 10 mg/24 hours). In most patients, the duration of treatment has been two to eight weeks, but several patients have received metyrosine for periods of 1 to 10 years.

Most patients with pheochromocytoma treated with metyrosine experience decreased frequency and severity of hypertensive attacks with their associated headache, nausea, sweating, and tachycardia. In patients who respond, blood pressure decreases progressively during the first two days of therapy with metyrosine; after withdrawal, blood pressure usually increases gradually to pretreatment values within two to three days. Metyrosine is well absorbed from the gastrointestinal tract.

From 53% to 88% (mean 69%) was recovered in the urine as unchanged drug following maintenance oral doses of 600 to 4,000 mg/24 hours in patients with pheochromocytoma or essential hypertension. Less than 1% of the dose was recovered as catechol metabolites. These metabolites are probably not present in sufficient amounts to contribute to the biochemical effects of metyrosine.

The quantities excreted, however, are sufficient to interfere with accurate determination of urinary catecholamines determined by routine techniques. Plasma half-life of metyrosine determined over an 8-hour period after single oral doses was 3 to 3.7 hours in three patients. For further information, refer to: Sjoerdsma A, Engelman K, Waldman TA, Cooperman LH, Hammond WG.

Pheochromocytoma: Current Concepts of Diagnosis and Treatment: Combined Clinical Staff Conference at the National Institutes of Health. Ann Intern Med. 1966;65:1302-1326.

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED Metyrosine Capsules USP, 250 mg are light blue opaque body with a print “315” /blue opaque cap with a print “C” filled with white to off-white powder. They are supplied as follows: NDC 75907-166-01 bottles of 100 NDC 75907-166-30 bottles of 30 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container.

Manufactured by: Cerovene Inc. Valley Cottage, NY 10989 Manufactured For: Dr. Reddy's Laboratories Inc.

Princeton, NJ 08540 USA Issued: 03/2024 CEROVENE

📦 Storage and Handling 40 words ▾

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container. Manufactured by: Cerovene Inc. Valley Cottage, NY 10989 Manufactured For: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA Issued: 03/2024 CEROVENE

📋 Description 128 words ▾

DESCRIPTION Metyrosine is (–)-α-methyl- L -tyrosine or (α-MPT). It has the following structural formula: Metyrosine USP is a white to off-white, crystalline compound of molecular weight 195.22. It is very slightly soluble in water, acetone, and methanol, and insoluble in chloroform and benzene.

It is soluble in acidic aqueous solutions. It is also soluble in alkaline aqueous solutions but is subject to oxidative degradation under these conditions. Metyrosine is supplied as capsules for oral administration.

Each capsule contains 250 mg metyrosine, USP. Inactive ingredients are colloidal silicon dioxide, FD&C Blue # 2, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains: black iron oxide, potassium hydroxide and shellac.

Meets USP Dissolution Test 2. structural formula

💬 Information for Patients 60 words ▾

Information for Patients When receiving metyrosine capsules, patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a motor vehicle or operating machinery. Metyrosine may have additive sedative effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, and tranquilizers. Patients should be advised to maintain a liberal fluid intake. (See PRECAUTIONS,General .)

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Metyrosine Crystalluria: Crystalluria and urolithiasis have been found in dogs treated with metyrosine at doses similar to those used in humans, and crystalluria has also been observed in a few patients. To minimize the risk of crystalluria, patients should be urged to maintain water intake sufficient to achieve a daily urine volume of 2,000 mL or more, particularly when doses greater than 2 g per day are given. Routine examination of the urine should be carried out.

Metyrosine will crystallize as needles or rods. If metyrosine crystalluria occurs, fluid intake should be increased further. If crystalluria persists, the dosage should be reduced or the drug discontinued.

Relatively Little Data Regarding Long-Term Use: The total human experience with the drug is quite limited and few patients have been studied long term. Chronic animal studies have not been carried out. Therefore, suitable laboratory tests should be carried out periodically in patients requiring prolonged use of metyrosine and caution should be observed in patients with impaired hepatic or renal function.

Information for Patients When receiving metyrosine capsules, patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a motor vehicle or operating machinery. Metyrosine may have additive sedative effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, and tranquilizers. Patients should be advised to maintain a liberal fluid intake.

(See PRECAUTIONS,General .) Drug Interactions Caution should be observed in administering metyrosine to patients receiving phenothiazines or haloperidol because the extrapyramidal effects of these drugs can be expected to be potentiated by inhibition of catecholamine synthesis. Concurrent use of metyrosine with alcohol or other CNS depressants can increase their sedative effects. (See WARNINGS and PRECAUTIONS , Information for Patients .) Laboratory Test Interference Spurious increases in urinary catecholamines may be observed in patients receiving metyrosine capsules due to the presence of metabolites of the drug.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenic studies in animals and studies on mutagenesis and impairment of fertility have not been performed with metyrosine. Pregnancy Pregnancy: Animal reproduction studies have not been conducted with metyrosine. It is also not known whether metyrosine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Metyrosine should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether metyrosine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when metyrosine is administered to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Geriatric Use Clinical studies of metyrosine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🍼 Nursing Mothers 33 words ▾

Nursing Mothers It is not known whether metyrosine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when metyrosine is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 24 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenic studies in animals and studies on mutagenesis and impairment of fertility have not been performed with metyrosine.

📄 Package Label / Principal Display Panel 40 words ▾

Principal Display Panel – 250 mg Bottle Label NDC 75907- 166 -30 Metyrosine Capsules, USP 250 mg Rx Only 30 Capsules Dr.Reddy’s NDC 75907- 166 -01 Metyrosine Capsules, USP 250 mg Rx Only 100 Capsules Dr.Reddy’s Metyrosine Capsule-30 Metyrosine Capsule-100

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

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

Medicare Part D (outpatient prescription) spending for Metyrosine — the program that covers self-administered drugs. 2 manufacturers.
⚠️ 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 Metyrosine. 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
$1.33M
Claims incl. refills
39
Beneficiaries
17
Spend / beneficiary
$78,194.00
Spend / claim
$34,084.56
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

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

Top reported reactions

Somnolence12
Diarrhoea6
Pneumonia6
Pyrexia6
Hospitalisation5
Malaise5
Phaeochromocytoma4

Age at onset

Adult11
Elderly5

Reporter sex

79 reports
Male · 57%
Female · 43%

Serious outcomes

Hospitalization33
Death20
Life-threatening5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Dr. Reddy's Laboratories Inc.. 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 30 capsules (75907-0166-30). 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?
Dr. Reddy's Laboratories Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 75907-0158-14 · Dr. 75907-0167-21 · DR. →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.