Medicine
Nitrofurantoin Monohydrate Macrocrystalline 25 mg/75 mg capsule
Nitrofurantoin Monohydrate Macrocrystalline 25 mg/75 mg capsule is a prescription medicine containing Nitrofurantoin for oral use, marketed by Direct_Rx, 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 (59° to 86°F or 15° to 30°C).
Key facts
- Active ingredient (INN)
- Nitrofurantoin
- Brand
- Nitrofurantoin Monohydrate Macrocrystalline
- Strength
- 25 mg/75 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 2 capsules, 10 capsules, 14 capsules
- Marketing authorisation holder
- Direct_Rx
- Manufacturer
- Direct_Rx
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature (59° to 86°F or 15° to 30°C).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01XE01 Nitrofurantoin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 July 2019
- Identifiers
- RxCUI 1648755DailyMed set ID 8d2e456a-ffb2-3f1e-e053-2995a90a22dfNDC 61919-021Application NDA020064
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
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 6 February 1953 | 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 Nitrofurantoin 25 mg/75 mg capsule.
Other strengths and forms of Nitrofurantoin
Clinical summary
Nitrofurantoin is a nitrofuran antibacterial indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcus species, Staphylococcus aureus. MedsAcross supplies Nitrofurantoin 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 NitrofurantoinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nitrofurantoin prescribing information (Rising Pharma Holdings) · U.S. National Library of Medicine, DailyMed
Need Nitrofurantoin Monohydrate Macrocrystalline 25 mg/75 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.