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Medicine

Daraprim 25 mg tablet

Pyrimethamine · Oral · TILDE Sciences
Available on requestPrescription onlyUS FDA

Daraprim 25 mg tablet is a prescription medicine containing Pyrimethamine for oral use, marketed by TILDE Sciences, 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 at 15° to 25°C (59° to 77°F) in a dry place and protect from light

Key facts

Active ingredient (INN)
Pyrimethamine
Brand
Daraprim
Strength
25 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 30 tablets and 1 more
Marketing authorisation holder
TILDE Sciences
Manufacturers
TILDE SciencesVyera Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
P01BD01 Pyrimethamine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
23 January 1953
Identifiers
RxCUI 198182, 201912DailyMed set ID 5368616d-6520-6f6e-2053-686b72656c69, f634f34b-0952-4dd3-9da3-f84b6ab823deNDC 69413-330, 83649-330Application NDA008578

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
100 tablet in 1 bottle, plastic83649-330-01TILDE Sciences12 December 2023
30 tablet in 1 bottle, plastic83649-330-03TILDE Sciences12 December 2023
100 tablet in 1 bottle, plastic69413-330-10Vyera Pharmaceuticals23 January 1953
30 tablet in 1 bottle, plastic69413-330-30Vyera Pharmaceuticals23 January 1953

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 23 January 1953Drugs@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

Alternatives

Other makers and brands of Pyrimethamine 25 mg tablet.

Compare 1

Clinical summary

Pyrimethamine is a dihydrofolate reductase inhibitor antimalarial indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. It is available as tablets for oral use. MedsAcross supplies Pyrimethamine 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 Pyrimethamine

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

Data sources

Need Daraprim 25 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.