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Pyrazinamide 500 mg Tablet, 500-count — NDC 70954-0484-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pyrazinamide 500 mg Tablet, 500-count — NDC 70954-484-40 (Billing 70954-0484-40)

by ANI Pharmaceuticals, Inc. · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of Pyrazinamide 500 mg Tablet from ANI Pharmaceuticals, Inc., no longer marketed (first marketed May 2021), no longer in the FDA NDC Directory.

NDC 70954-0484-40
🏷️ FDA NDC (as labeled) 70954-484-40 billing pads the product segment with a zero
This package
Contains500-count Pack sizes4 compare ↓
Product page 70954-0484-30 Also comes in: 60 tablets 70954-484-10 90 tablets 70954-484-20 100 tablets 70954-484-30
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 70954-484-40 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70954 labeler · 484 product · 40 package
Listing certified through
Dec 31, 2027
Billing quantity
500 EA per package
Barcode (UPC)
0370954484103, 0370954484301, 0370954484202
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70954-484-40
Product NDC 70954-484
11-digit billing NDC 70954048440
NCPDP billing unit EA — each (per item)
RxCUI 198181
UNII 2KNI5N06TI
UPC 0370954484103, 0370954484301, 0370954484202
Application # ANDA080157
SPL Set ID 262d8829-728c-48db-b89b-88d13b87e684
Established class (EPC) Antimycobacterial
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2021-05-11
Route ORAL
Dosage form TABLET
Substance PYRAZINAMIDE
TE code (Orange Book) AB · RLD · RS

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

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
Quick answers
  • GSN (GCN sequence number): 009424
  • GCN: 41790
  • GPI-14 (Medi-Span): 09000070000310
  • HICL (First Databank): 004084
  • AHFS class code: 08:16.04.00
  • RxCUI (RxNorm): 198181
Why two NDCs? The FDA registers this code as 70954-484-40 — 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 → 70954-0484-40. 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.

Clinical

Label name PYRAZINAMIDE 500 MG TABLET Ingredient Pyrazinamide
📗 Our plain-language guide HelloPharmacist
  • It treats active tuberculosis in adults and children. It is never used alone. You take it with other TB medicines, usually during the first two months of treatment.
  • You swallow the tablets by mouth, usually once a day. Take it exactly as your prescriber and the label direct. Do not skip doses, because TB treatment depends on taking every medic...
  • Nausea, vomiting, poor appetite, and mild joint or muscle aches are the most common. Some people get a rash or itching. Let your doctor know if these bother you.
  • Call if you notice signs of liver trouble, a sudden painful gout flare, an allergic reaction, or unusual bleeding. Liver problems are the main serious concern and can happen at any...
📖 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.

🧪 Full Pyrazinamide nutrient depletion report →
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.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 tablets 90 tablets 100 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
70954-0484-10 70954-484-10 60 TABLET in 1 BOTTLE $1.31 / ea $78.48 2021-05-11 — Active
70954-0484-20 70954-484-20 90 TABLET in 1 BOTTLE $1.31 / ea $117.73 2021-05-11 — Active
70954-0484-30 70954-484-30 Main listing 100 TABLET in 1 BOTTLE $1.31 / ea $130.81 2021-05-11 — Active
70954-0484-40 You're viewing this 500 TABLET in 1 BOTTLE — — 2021-05-11 — Discontinued by firm

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 the largest share of fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 70954-0484-10?
Both are Pyrazinamide 500 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 70954-0484-10 is the 60 tablets package.
What NDC number is used to bill for this package of Pyrazinamide 500 mg Tablet?
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.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
pyrazinamide 500 mg 00054-0812-21 Hikma 60 tablets $1.308 AB Availability likely —
Pyrazinamide 500 mg 60687-0789-01 American 100 tablets $1.308 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 —
Pyrazinamide 500 mgthis 70954-0484-40 ANI 500 tablets — AB Discontinued —
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

🏛️
2021
On the market since
May 2021
📍
2026
Currently FDA-listed
5 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.

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.

🧪 Avoiding an ingredient? See Pyrazinamide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerANI Pharmaceuticals, Inc.
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA080157 (ANDA)
Labeler code70954
First marketedMay 2021
Product typeHuman Prescription Drug
Portfolio299 products on file

More NDCs from ANI Pharmaceuticals, Inc. labeler code 70954

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 / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 163 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 recommendations 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 to 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 70 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. The 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* Maximal Daily Dose in Children and Adults Twice Weekly Dose 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 19 words ▾

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

⚠️ Warnings 59 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 118 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 pruritus have been reported.

Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely.

🔄 Drug / Laboratory Test Interactions 26 words ▾

DRUG & OR LABORATORY TEST INTERACTIONS Pyrazinamide has been reported to interfere with ACETEST ® and KETOSTIX ® urine tests to produce a pink-brown color. 5

🤰 Pregnancy 50 words ▾

PREGNANCY Teratogenic Effects – Pregnancy Category C 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 26 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 113 words ▾

GERIATRIC USE 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 197 words ▾

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 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 74 words ▾

HOW SUPPLIED Pyrazinamide Tablets, USP 500 mg are round, white, scored tablets, debossed "N" above the score and "484" below the score. NDC 70954-484-10 - Bottle of 60 NDC 70954-484-20 - Bottle of 90 NDC 70954-484-30 - Bottle of 100 NDC 70954-484-40 - Bottle of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 58 words ▾

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: Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: Corn Starch, Magnesium Stearate, Pregelatinized Starch and Stearic Acid. 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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS GENERAL PRECAUTIONS Pyrazinamide inhibits renal excretion of urates, frequently resulting in hyperuricemia which is usually asymptomatic. If hyperuricemia is accompanied by acute gouty arthritis, pyrazinamide should be discontinued. Pyrazinamide should be used with caution in patients with a history of diabetes mellitus, as management may be more difficult.

Primary resistance of M. tuberculosis to pyrazinamide is uncommon. In cases with known or suspected drug resistance, in vitro susceptibility tests with recent cultures of M. tuberculosis against pyrazinamide and the usual primary drugs should be performed. There are few reliable in vitro tests for pyrazinamide resistance.

A reference laboratory capable of performing these studies must be employed. 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.

LABORATORY TESTS Baseline liver function studies [especially ALT (SGPT), AST (SGOT) determinations] and uric acid levels should be determined prior to therapy. Appropriate laboratory testing should be performed at periodic intervals and if any clinical signs or symptoms occur during therapy. DRUG & OR LABORATORY TEST INTERACTIONS Pyrazinamide has been reported to interfere with ACETEST ® and KETOSTIX ® urine tests to produce a pink-brown color.

5 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY In lifetime bioassays in rats and mice, pyrazinamide was administered in the diet at concentrations of up to 10,000 ppm. This resulted in estimated daily doses for the mouse of 2 g/kg, or 40 times the maximum human dose, and for the rat of 0.5 g/kg, or 10 times the maximum human dose. Pyrazinamide was not carcinogenic in rats or male mice and no conclusion was possible for female mice due to insufficient numbers of surviving control mice.

Pyrazinamide was not mutagenic in the Ames bacterial test, but induced chromosomal aberrations in human lymphocyte cell cultures. PREGNANCY Teratogenic Effects – Pregnancy Category C 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. NURSING MOTHERS Pyrazinamide has been found in small amounts in breast milk. Therefore, it is advised that pyrazinamide be used with caution in nursing mothers taking into account the risk-benefit of this therapy.

9 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 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

🍼 Nursing Mothers 34 words ▾

NURSING MOTHERS Pyrazinamide has been found in small amounts in breast milk. Therefore, it is advised that pyrazinamide be used with caution in nursing mothers taking into account the risk-benefit of this therapy. 9

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 103 words ▾

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY In lifetime bioassays in rats and mice, pyrazinamide was administered in the diet at concentrations of up to 10,000 ppm. This resulted in estimated daily doses for the mouse of 2 g/kg, or 40 times the maximum human dose, and for the rat of 0.5 g/kg, or 10 times the maximum human dose. Pyrazinamide was not carcinogenic in rats or male mice and no conclusion was possible for female mice due to insufficient numbers of surviving control mice.

Pyrazinamide was not mutagenic in the Ames bacterial test, but induced chromosomal aberrations in human lymphocyte cell cultures.

📚 References ~1 min read ▾

REFERENCES Drug Information, American Hospital Formulary Service . American Society of Hospital Pharmacists. Bethesda, MD.

1991. USPDI, Drug Information for the Health Care Professional . United States Pharmacopeial Convention, Inc.

Rockville, MD. 1991:1B:2226-2227. Goodman-Gilman A, Rall TW, Nies AS, Taylor P.

The Pharmacological Basis of Therapeutics , ed 8. New York, Pergamon Press. 1990;1154.

Treatment of tuberculosis and tuberculosis infection in adults and children. Am Rev Respir Dis . 1986;134:363-368.

Reynolds JEF, Parfitt K, Parsons AV, Sweetman SC. Martindale The Extra Pharmacopoeia , ed 29. London, The Pharmaceutical Press.

1989;569-570. Bioassay of pyrazinamide for possible carcinogenicity. National Cancer Institute Carcinogenesis Technical Report Series No.

48, 1978. Zerger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W. Salmonella mutagenicity tests:III.

Results from the testing of 255 chemicals. Environ Mutagen . 1987;9 (Suppl 9):1-109.

Roman IC, Georgian L. Cytogenetic effects of some antituberculosis drugs in vitro. Mutation Research .

1977;48:215-224. Holdiness M. Antituberculosis drugs and breast-feeding.

Arch Intern Med . 1984;144:1888. Turcios N, Evans H.

Preventing and managing tuberculosis in children. J Resp Dis . 1989;10(6)(Jun):23.

Starke JR. Multidrug therapy for tuberculosis in children. Pediatr Infec Dis J .

1990;9:785793. Specific requirements on content and format of labeling for human prescription drugs; proposed addition of "geriatric use" subsection in the labeling. Federal Register .

1990;55(212)(Nov 1):46134-46137. Stamathakis G, Montes C, Trouvin JH, et al. Pyrazinamide and pyrazinoic acid pharmacokinetics in patients with chronic renal failure.

Clinical Nephrology . 1988;30:230-234. All trademarks are the property of their respective owners.

Manufactured by: Novitium Pharma, LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 01/2021 LB4280-00

📄 Package Label / Principal Display Panel 37 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Pyrazinamide Tablets, USP 500 mg 70954-484-10 - Bottle of 60 Pyrazinamide Tablets, USP 500 mg 70954-484-20 - Bottle of 90 Pyrazinamide Tablets, USP 500 mg 70954-484-30 - Bottle of 100 container-60 container-90 container-100

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

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 tablets70954-0484-30 250 Rx · $43,843
60 tablets70954-0484-10 219 Rx · $37,940
90 tablets70954-0484-20 101 Rx · $20,943
500 tablets this page70954-0484-40 No Medicaid data
Drug total (last 4 qtrs): 570 Rx · 40,210 units · $102,726 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 60 tablets (70954-0484-10), 90 tablets (70954-0484-20), 100 tablets (70954-0484-30). 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?
ANI Pharmaceuticals, 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.
← 70954-0481-10 · Novitium 70954-0488-10 · ANI →
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.