Medicine
Pyrazinamide 500 mg tablet
Pyrazinamide 500 mg tablet is a generic prescription medicine for oral use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store in a well-closed container at controlled room temperature 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Pyrazinamide
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 10 tablets, 30 tablets, 60 tablets and 15 more
- Manufacturers
- Macleods PharmaceuticalsIndiaHikma PharmaceuticalsANI PharmaceuticalsMarlex PharmaceuticalsAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store in a well-closed container at controlled room temperature 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J04AK01 Pyrazinamide
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 July 2020
- Identifiers
- RxCUI 198181DailyMed set ID 566db230-3d73-482f-b67d-defd0b2dc46c, db250a85-2e20-87e9-e053-2a95a90a72b6, a8b7ba02-8509-475b-8a3b-39d205af3f1e +2NDC 0054-0812, 10135-735, 33342-447 +2Application ANDA081319, ANDA080157, ANDA212541
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 tablet in 1 bottle | 33342-447-03 | Macleods PharmaceuticalsIndia | 27 July 2020 |
| 30 tablet in 1 bottle | 33342-447-07 | Macleods PharmaceuticalsIndia | 27 July 2020 |
| 60 tablet in 1 bottle | 33342-447-09 | Macleods PharmaceuticalsIndia | 27 July 2020 |
| 90 tablet in 1 bottle | 33342-447-10 | Macleods PharmaceuticalsIndia | 27 July 2020 |
| 100 tablet in 1 bottle | 33342-447-11 | Macleods PharmaceuticalsIndia | 27 July 2020 |
| 10 tablet in 1 blister pack | 33342-447-12 | Macleods PharmaceuticalsIndia | 27 July 2020 |
| 500 tablet in 1 bottle | 33342-447-15 | Macleods PharmaceuticalsIndia | 27 July 2020 |
| 60 tablet in 1 bottle | 70954-484-10 | ANI Pharmaceuticals | 11 May 2021 |
| 90 tablet in 1 bottle | 70954-484-20 | ANI Pharmaceuticals | 11 May 2021 |
| 100 tablet in 1 bottle | 70954-484-30 | ANI Pharmaceuticals | 11 May 2021 |
| 60 tablet in 1 container | 0054-0812-21 | Hikma Pharmaceuticals | 30 August 2024 |
| 90 tablet in 1 container | 0054-0812-22 | Hikma Pharmaceuticals | 30 August 2024 |
| 100 tablet in 1 container | 0054-0812-25 | Hikma Pharmaceuticals | 30 August 2024 |
| 500 tablet in 1 container | 0054-0812-29 | Hikma Pharmaceuticals | 30 August 2024 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-789-01 | American Health Packaging | 20 February 2024 |
| 100 tablet in 1 bottle | 10135-735-01 | Marlex Pharmaceuticals | 1 March 2022 |
| 60 tablet in 1 bottle | 10135-735-60 | Marlex Pharmaceuticals | 1 March 2022 |
| 90 tablet in 1 bottle | 10135-735-90 | Marlex Pharmaceuticals | 1 March 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | Approved | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Pyrazinamide is an antimycobacterial indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. It is available as tablets for oral use. MedsAcross supplies Pyrazinamide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about PyrazinamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Pyrazinamide prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Pyrazinamide 500 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.