Medicine
Metyrosine 250 mg capsule
Metyrosine 250 mg capsule is a generic prescription medicine for oral use, made by 3 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 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Metyrosine
- Brand
- Sold under the generic name
- Strength
- 250 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 30 capsules and 2 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaAmneal PharmaceuticalsOceanside Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C02KB01 Metyrosine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 July 2020
- Identifiers
- RxCUI 197980DailyMed set ID 46612725-bee0-4125-b8b5-9fed9c003ed4, 027f02b1-be49-4822-91a5-6cd66b56c0e1, 1b7897b4-7681-4b99-8883-d5dc33f86c01NDC 68682-310, 69238-1621, 75907-166Application NDA017871, ANDA213734, ANDA218620
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 capsule in 1 bottle | 75907-166-01 | Dr. Reddy's LaboratoriesIndia | 30 May 2025 |
| 30 capsule in 1 bottle | 75907-166-30 | Dr. Reddy's LaboratoriesIndia | 30 May 2025 |
| 100 capsule in 1 bottle, plastic | 69238-1621-1 | Amneal Pharmaceuticals | 24 July 2020 |
| 30 capsule in 1 bottle, plastic | 69238-1621-3 | Amneal Pharmaceuticals | 15 December 2020 |
| 100 capsule in 1 bottle | 68682-310-01 | Oceanside Pharmaceuticals | 7 September 2020 |
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 3 October 1979 | 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
Alternatives
Other makers and brands of Metyrosine 250 mg capsule.
Clinical summary
Metyrosine is a catecholamine synthesis inhibitor indicated in the treatment of patients with pheochromocytoma for 1. It is available as capsules for oral use. MedsAcross supplies Metyrosine 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 MetyrosineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Demser prescribing information (Bausch Health) · U.S. National Library of Medicine, DailyMed
Need Metyrosine 250 mg capsule 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.