Medicine
Propylthiouracil 50 mg tablet
Propylthiouracil 50 mg tablet is a generic prescription medicine for oral use, made by 7 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 at controlled room temperature 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Propylthiouracil
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 10 blister pack, 1000 tablets and 10 more
- Manufacturers
- Macleods PharmaceuticalsIndiaBryant Ranch PrepackPar HealthQuagen PharmaceuticalsAmerican Health PackagingChartwell RXTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H03BA02 Propylthiouracil
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 July 1947
- Identifiers
- RxCUI 198175DailyMed set ID 84eae11a-b572-4570-b288-ac2cdd374186, a251e4cb-01f1-4fd8-bd30-362126b85073, d819e532-09ac-434a-84a6-636c4204c7aa +5NDC 70752-171, 33342-314, 68084-964 +5Application ANDA080154, ANDA208867, NDA006188 +2
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 33342-314-11 | Macleods PharmaceuticalsIndia | 10 May 2023 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-314-12 | Macleods PharmaceuticalsIndia | 10 May 2023 |
| 1000 tablet in 1 bottle | 33342-314-44 | Macleods PharmaceuticalsIndia | 10 May 2023 |
| 90 tablet in 1 bottle | 62135-606-90 | Chartwell RX | 19 December 2023 |
| 100 tablet in 1 bottle | 67253-651-10 | Par Health | 28 July 1947 |
| 1000 tablet in 1 bottle | 67253-651-11 | Par Health | 28 July 1947 |
| 100 tablet in 1 bottle | 70752-171-10 | Quagen Pharmaceuticals | 18 March 2021 |
| 1000 tablet in 1 bottle | 70752-171-11 | Quagen Pharmaceuticals | 18 March 2021 |
| 100 tablet in 1 bottle | 0480-9242-01 | Teva Pharmaceuticals | 10 July 2024 |
| 100 tablet in 1 bottle | 71335-2901-1 | Bryant Ranch Prepack | 11 November 2025 |
| 100 tablet in 1 bottle | 72162-2072-1 | Bryant Ranch Prepack | 15 August 2023 |
| 180 tablet in 1 bottle | 72162-2072-2 | Bryant Ranch Prepack | 15 August 2023 |
| 30 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 68084-964-25 | American Health Packaging | 8 October 2015 |
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 | First approved 28 July 1947 | 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
Propylthiouracil is a thyroid hormone synthesis inhibitor indicated in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Propylthiouracil 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 PropylthiouracilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Propylthiouracil prescribing information (Par Health) · U.S. National Library of Medicine, DailyMed
Need Propylthiouracil 50 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.