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Medicine

Metopirone 250 mg capsule

Metyrapone · Oral · Esteve Pharmaceuticals
Available on requestPrescription onlyUS FDA

Metopirone 250 mg capsule is a prescription medicine containing Metyrapone for oral use, marketed by Esteve Pharmaceuticals, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store Metopirone bottles at room temperature 20°C to 25°C (68°F to 77°F)…

Key facts

Active ingredient (INN)
Metyrapone
Brand
Metopirone
Strength
250 mg
Dosage form
Capsule
Route
Oral
Packs
18 capsules
Marketing authorisation holder
Esteve Pharmaceuticals
Manufacturers
Esteve PharmaceuticalsHRA Pharma Rare Diseases
Origin register
US FDA, United States
Storage
Store Metopirone bottles at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Keep container tightly closed and protect from heat and moisture.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
V04CD01 Metyrapone
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
25 January 1962
Identifiers
RxCUI 105450, 199772DailyMed set ID 4046b167-7a46-8f4a-e063-6394a90a147f, 3a27d0ef-83a7-4e1c-9430-46a3326ee8d8NDC 68118-455, 76336-455Application NDA012911

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

PackCodeLabelerMarketed since
18 capsule, gelatin coated in 1 bottle68118-455-18Esteve Pharmaceuticals25 January 1962
18 capsule, gelatin coated in 1 bottle76336-455-18HRA Pharma Rare Diseases25 January 1962

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 4 December 1961Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Metyrapone is an adrenal steroid synthesis inhibitor indicated , in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. It is available as capsules for oral use. MedsAcross supplies Metyrapone 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 Metyrapone

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Metopirone 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.