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Pyrazinamide 500 mg Tablet, 90-count — NDC 33342-0447-10 package photo

Pyrazinamide 500 mg Tablet, 90-count

by Macleods Pharmaceuticals Limited · 90 TABLET in 1 BOTTLE (33342-447-10)
NDC 33342-0447-10
🏷️ FDA NDC (as labeled) 33342-447-10 billing pads the product segment with a zero
This package
Contains90-count Pack sizes7 compare ↓
Also priced by: Part D plans $3.00/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 33342-447-10
Product NDC 33342-447
11-digit billing NDC 33342044710
RxCUI 198181
UNII 2KNI5N06TI
UPC 0333342447104, 0333342447098, 0333342447111, 0333342447159
Application # ANDA212541
SPL Set ID a8b7ba02-8509-475b-8a3b-39d205af3f1e
Established class (EPC) Antimycobacterial
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-27
Route ORAL
Dosage form TABLET
Substance PYRAZINAMIDE
GPI-14 09000070000310
GPI class Pyrazinamide
GCN Seq No 009424
GCN 41790
HICL code 004084
Ingredient (HICL) Pyrazinamide
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2E
Therapeutic class — specific (HIC3) Anti-Mycobacterium Agents
AHFS code 08:16.04.00
AHFS class Antituberculosis Agents
FDB label name PYRAZINAMIDE 500 MG TABLET
FDB brand name Pyrazinamide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 33342-447-10 — 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 → 33342-0447-10. 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 Antimycobacterial class.

Pharmacologic class Antimycobacterial
Drug family (ATC) Other drugs for treatment of tuberculosis
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

LabelerMacleods Pharmaceuticals Limited
Application holderMACLEODS PHARMACEUTICALS LTD
FDA applicationANDA212541 (ANDA)
Labeler code33342
First marketedJul 2020
Product typeHuman Prescription Drug
Portfolio381 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 PYRAZINAMIDE 500 MG TABLET Ingredient Pyrazinamide
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Pyrazinamide guide →
8
Nutrient depletion considerations

Pyrazinamide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
ShapeRound
ImprintF;43
Size12 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

6 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 DailyMedingredient 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 $3.00 $270.09 / 90 tablets
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
pyrazinamide 500 mg 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 mgthis 33342-0447-10 Macleods 90 tablets 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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 years 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.

💊 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.
100 tablets33342-0447-11 998 Rx · $197,123
10 tablets33342-0447-03 No Medicaid data
30 tablets33342-0447-07 No Medicaid data
60 tablets33342-0447-09 No Medicaid data
10 tablets33342-0447-12 No Medicaid data
500 tablets33342-0447-15 No Medicaid data
Drug total (last 4 qtrs): 998 Rx · 79,506 units · $197,123 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 Pyrazinamide — the program that covers self-administered drugs. 3 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 Pyrazinamide. 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
$145.5K
Claims incl. refills
579
Beneficiaries
379
Spend / beneficiary
$383.80
Spend / claim
$251.22
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
33342-0447-03 10 TABLET in 1 BOTTLE (33342-447-03) 2020-07-27 Active
33342-0447-07 30 TABLET in 1 BOTTLE (33342-447-07) 2020-07-27 Active
33342-0447-09 60 TABLET in 1 BOTTLE (33342-447-09) 2020-07-27 Active
33342-0447-10 You're viewing this 90 TABLET in 1 BOTTLE (33342-447-10) 2020-07-27 Active
33342-0447-11 100 TABLET in 1 BOTTLE (33342-447-11) $1.33 / ea $132.76 2020-07-27 Active
33342-0447-12 10 TABLET in 1 BLISTER PACK (33342-447-12) 2020-07-27 Active
33342-0447-15 500 TABLET in 1 BOTTLE (33342-447-15) $1.33 / ea $663.81 2020-07-27 Active

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 33342-0447-10?
NDC 33342-0447-10 is a 90-count package — 90 tablet in 1 bottle.
What is the difference between NDC 33342-0447-10 and NDC 33342-0447-03?
Both are Pyrazinamide 500 mg Tablet — the drug itself is identical. NDC 33342-0447-10 is the 90-count package, while NDC 33342-0447-03 is the 10 tablets package.
What NDC number is used to bill for this package of Pyrazinamide 500 mg Tablet?
Bill NDC 33342-0447-10 — the 11-digit billing format is 33342044710. 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 33342-447-10, 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: 33342-0447-10, written without dashes as 33342044710. 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 33342-0447-10, the first segment (33342) is the labeler code FDA assigned to Macleods Pharmaceuticals Limited; the middle segment (0447) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Macleods Pharmaceuticals Limited. 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 6 other package presentations of this same product, including 10 tablets (33342-0447-03), 10 tablets (33342-0447-12), 30 tablets (33342-0447-07). 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?
Macleods Pharmaceuticals Limited 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.

📄 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 164 words

INDICATIONS & 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 ~2 min read

DOSAGE & 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 Daily Dose * Maximal Daily Dose in Children and Adults Twice Weekly Dose Drug Children Adults Children Adults Isoniazid 10 to 20 mg/kg PO or IM 5 mg/kg PO or IM 300 mg 20 to 40 mg/kg Max. 900 mg 15 mg/kg Max. 900 mg Rifampin 10 to 20 mg/kg PO 10 mg/kg PO 600 mg 10 to 20 mg/kg Max.

600 mg 10 mg/kg Max. 600 mg Pyrazinamide 15 to 30 mg/kg PO 15 to 30 mg/kg PO 2 g 50 to 70 mg/kg 50 to 70 mg/kg Streptomycin 20 to 40 mg/kg IM 15 mg/kg** IM 1 g** 25 to 30 mg/kg IM 25 to 30 mg/kg IM Ethambutol 15 to 25 mg/kg PO 15 to 25 mg/kg PO 2.5 g 50 mg/kg 50 mg/kg Definition of abbreviations: PO = perorally; IM = intramuscularly. * Doses based on weight should be adjusted as weight changes. **In persons older than 60 yrs of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.

Contraindications 22 words

CONTRAINDICATIONS: Pyrazinamide is contraindicated in persons: • with severe hepatic damage. • who have shown hypersensitivity to it. • with acute gout.

⚠️ Warnings 58 words

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 117 words

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 / Laboratory Test Interactions 23 words

Drug/Laboratory Test Interactions: Pyrazinamide has been reported to interfere with ACETEST ® and KETOSTIX ® urine tests to produce a pink-brown color. 5

🤰 Pregnancy 46 words

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 24 words

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 114 words

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 38 words

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 ~1 min read

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. Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

📦 How Supplied / Storage and Handling 144 words

HOW SUPPLIED Pyrazinamide Tablets, USP 500 mg are round, white to off white uncoated, scored tablets with notches, debossed "F" above the score and "43" below the score and plain on other side. Tablets are supplied in the following strengths and package configurations: Package configuration NDC number Bottles of 10 33342-447-03 Bottles of 30 33342-447-07 Bottles of 60 33342-447-09 Bottles of 90 33342-447-10 Bottles of 100 33342-447-11 Bottles of 500 33342-447-15 Carton of 100 Tablets (10 x 10 unit dose) 33342-447-12 Store at 20° to 25° C (68° F to 77° F); excursions permitted between 15° to 30° C (59° F to 86° F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by: Macleods Pharmaceutical Ltd.

Daman, (U.T.), INDIA Revised: December 2022

📋 Description 65 words

DESCRIPTION: Pyrazinamide, USP 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 USP has the following structural formula: Each pyrazinamide tablet, USP for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: corn starch, colloidal silicon dioxide, magnesium stearate, povidone, sodium starch glycolate and talc. pyrazinamide-structure

💬 Information for Patients 63 words

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.

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