pyrazinamide 500 mg Tablet, 60-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Antimycobacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Pyrazinamide kills or stops the growth of certain bacteria that cause tuberculosis (TB). It is used with other drugs to treat tuberculosis. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- TB is a tough infection, and using just one antibiotic gives the bacteria a chance to become resistant and stop responding to treatment. Pyrazinamide works best — and helps protect...
- Why do I have to take so many pills at once — can't I just take pyrazinamide by itself?
- The standard plan recommended by the CDC is a 6-month course for drug-susceptible TB. Pyrazinamide is typically used during the first 2 months of that period, alongside other medic...
- How long will I need to take this medication?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pyrazinamide — tap one for details:
Pyrazinamide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
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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.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.328 | $79.66 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $2.56 | $153.36 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $3.00 | $180.06 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| pyrazinamide 500 mgthis 00054-0812-21 | Hikma | 60 tablets | $1.328 | AB | Availability likely | — |
| Pyrazinamide 500 mg 60687-0789-01 | American | 100 tablets | $1.328 | AB | Availability likely | — |
| Pyrazinamide 500 mg 70954-0484-10 | ANI | 60 tablets | $1.328 | AB | Availability likely | — |
| Pyrazinamide 500 mg 10135-0735-01 | MARLEX | 100 tablets | — | AB | FDA listed | — |
| Pyrazinamide 500 mg 33342-0447-03 | Macleods | 10 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00054-0812-21 You're viewing this | 60 TABLET in 1 CONTAINER (0054-0812-21) | $1.33 / ea | $79.66 | 2024-08-30 | Active |
| 00054-0812-22 | 90 TABLET in 1 CONTAINER (0054-0812-22) | $1.33 / ea | $119.49 | 2024-08-30 | Active |
| 00054-0812-25 | 100 TABLET in 1 CONTAINER (0054-0812-25) | $1.33 / ea | $132.76 | 2024-08-30 | Active |
| 00054-0812-29 | 500 TABLET in 1 CONTAINER (0054-0812-29) | $1.33 / ea | $663.81 | 2024-08-30 | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 4 priced pack sizes ($1.33 NADAC).
Pack size FAQ
What quantity is in NDC 00054-0812-21?
What is the difference between NDC 00054-0812-21 and NDC 00054-0812-22?
What NDC number is used to bill for this package of pyrazinamide 500 mg Tablet?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.* 4 ) (Patients with drug-resistant disease should be treated with regimens individualized to their situation.
Pyrazinamide frequently will be an important component of such therapy.) (In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment). It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis.
Pyrazinamide should only be used in conjunction with other effective antituberculous agents. *See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations. 4
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Pyrazinamide should always be administered with other effective antituberculous drugs. It is administered for the initial 2 months of a 6-month or longer treatment regimen for drug-susceptible patients. Patients who are known or suspected to have drug-resistant disease should be treated with regimens individualized to their situation.
Pyrazinamide frequently will be an important component of such therapy. Patients with concomitant HIV infection may require longer courses of therapy. Physicians treating such patients should be alert to any revised recommendations from CDC for this group of patients.
Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 or 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded.
The CDC recommendations do not exceed 2 g per day when given as a daily regimen (see table). Alternatively, a twice weekly dosing regimen (50 to 75 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluating the twice weekly regimen, doses of pyrazinamide in excess of 3 g twice weekly have been administered.
This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported. This table is taken from the CDC-American Thoracic Society joint recommendations.
4 Recommended Drugs for the Initial Treatment of Tuberculosis in Children and Adults Drug Daily Dose* Children Adults Isoniazid 10 to 20 mg/kg PO or IM 5 mg/kg PO or IM Rifampin 10 to 20 mg/kg PO 10 mg/kg PO Pyrazinamide 15 to 30 mg/kg PO 15 to 30 mg/kg PO Streptomycin 20 to 40 mg/kg IM 15 mg/kg IM Ethambutol 15 to 25 mg/kg PO 15 to 25 mg/kg PO Drug Maximal Daily Dose in Children and Adults Isoniazid 300 mg Rifampin 600 mg Pyrazinamide 2 g Streptomycin 1 g** Ethambutol 2.5 g Drug Twice Weekly Dose Children Adults Isoniazid 20 to 40 mg/kg Max.
900 mg 15 mg/kg Max. 900 mg Rifampin 10 to 20 mg/kg Max. 600 mg 10 mg/kg Max.
600 mg Pyrazinamide 50 to 70 mg/kg 50 to 70 mg/kg Streptomycin 25 to 30 mg/kg IM 25 to 30 mg/kg IM Ethambutol 50 mg/kg 50 mg/kg Definition of abbreviations: PO = perorally; IM = intramuscularly.
⛔ Contraindications ▾
CONTRAINDICATIONS Pyrazinamide is contraindicated in persons: • with severe hepatic damage. • who have shown hypersensitivity to it. • with acute gout.
⚠️ Warnings ▾
WARNINGS Patients started on pyrazinamide should have baseline serum uric acid and liver function determinations. Those patients with preexisting liver disease or those at increased risk for drug related hepatitis (e.g., alcohol abusers) should be followed closely. Pyrazinamide should be discontinued and not be resumed if signs of hepatocellular damage or hyperuricemia accompanied by an acute gouty arthritis appear.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS General Fever, porphyria and dysuria have rarely been reported. Gout (see PRECAUTIONS ). Gastrointestinal The principal adverse effect is a hepatic reaction (see WARNINGS ).
Hepatotoxicity appears to be dose related, and may appear at any time during therapy. GI disturbances including nausea, vomiting and anorexia have also been reported. Hematologic and Lymphatic Thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes and increased serum iron concentration have occurred rarely with this drug.
Adverse effects on blood clotting mechanisms have also been rarely reported. Other Mild arthralgia and myalgia have been reported frequently. Hypersensitivity reactions including rashes, urticaria, and pruritis have been reported.
Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely.
🔄 Drug Interactions ▾
Interactions Drug/Laboratory Test Interactions Pyrazinamide has been reported to interfere with ACETEST ® and KETOSTIX ® urine tests to produce a pink-brown color. 5
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Pyrazinamide has been reported to interfere with ACETEST ® and KETOSTIX ® urine tests to produce a pink-brown color. 5
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with pyrazinamide. It is also not known whether pyrazinamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyrazinamide should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Pyrazinamide regimens employed in adults are probably equally effective in pediatric patients. 4,10,11 Pyrazinamide appears to be well tolerated in pediatric patients.
🧓 Geriatric Use ▾
Geriatric Use 12 Clinical studies of pyrazinamide did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 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 or renal function, and of concomitant disease or other drug therapy.
It does not appear that patients with impaired renal function require a reduction in dose. It may be prudent to select doses at the low end of the dosing range, however. 13
🆘 Overdosage ▾
OVERDOSAGE Overdosage experience is limited. In one case report of overdose, abnormal liver function tests developed. These spontaneously reverted to normal when the drug was stopped. Clinical monitoring and supportive therapy should be employed. Pyrazinamide is dialyzable. 13
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pyrazinamide is well absorbed from the GI tract and attains peak plasma concentrations within 2 hours. Plasma concentrations generally range from 30 to 50 mcg/mL with doses of 20 to 25 mg/kg. It is widely distributed in body tissues and fluids including the liver, lungs and cerebrospinal fluid (CSF).
The CSF concentration is approximately equal to concurrent steady-state plasma concentrations in patients with inflamed meninges. 1 Pyrazinamide is approximately 10% bound to plasma proteins. 2 The half-life (t 1/2 ) of pyrazinamide is 9 to 10 hours in patients with normal renal and hepatic function.
The plasma half-life may be prolonged in patients with impaired renal or hepatic function. Pyrazinamide is hydrolyzed in the liver to its major active metabolite, pyrazinoic acid. Pyrazinoic acid is hydroxylated to the main excretory product, 5-hydroxypyrazinoic acid.
3 Approximately 70% of an oral dose is excreted in the urine, mainly by glomerular filtration within 24 hours. 3 Pyrazinamide may be bacteriostatic or bactericidal against Mycobacterium tuberculosis depending on the concentration of the drug attained at the site of infection. The mechanism of action is unknown.
In vitro and in vivo the drug is active only at a slightly acidic pH.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Pyrazinamide Tablets, USP contain pyrazinamide 500 mg. They are supplied as white, round, scored tablets debossed “VP/012” in containers of 60 tablets, NDC# 0054-0812-21, in containers of 90 tablets, NDC# 0054-0812-22, in containers of 100 tablets, NDC# 0054-0812-25, and in containers of 500 tablets, NDC# 0054-0812-29. Storage: Store in a well-closed container at controlled room temperature 15°C to 30°C (59°F to 86°F).
Dispense in a well-closed container with a child resistant closure. Rx only Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Manufactured by: Mikart, LLC Atlanta, GA 30318 1191B00 H/01 Revised: October 2023
📋 Description ▾
DESCRIPTION Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula: C 5 H 5 N 3 O M.W.
123.11 Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid. structural formula image
💬 Information for Patients ▾
Information for Patients Patients should be instructed to notify their physicians promptly if they experience any of the following: fever, loss of appetite, malaise, nausea and vomiting, darkened urine, yellowish discoloration of the skin and eyes, pain or swelling of the joints. Compliance with the full course of therapy must be emphasized, and the importance of not missing any doses must be stressed.