Medicine
Nitrofurantoin 50 mg capsule
Nitrofurantoin 50 mg capsule is a generic prescription medicine for oral use, made by 15 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)
- Nitrofurantoin
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 1000 capsules, 10 blister pack and 33 more
- Manufacturers
- Zydus LifesciencesIndiaAlembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaLifestar PharmaIndiaLupinIndiaBryant Ranch PrepackProficient RxAmerican Health PackagingAmneal Pharmaceuticals of New York
- 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
- J01XE01 Nitrofurantoin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 March 2007
- Identifiers
- RxCUI 311995, 1648759, 311994DailyMed set ID 158e08ff-9b6d-4d60-a218-74dc289cf023, 29b72c21-ab85-41de-b025-f139e6e13ccc, 3ee5e79f-1dca-4e1b-95a9-7859bfe344d1 +14NDC 59651-753, 71205-023, 0904-7026 +14Application ANDA074967, NDA016620, ANDA205005 +5
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 | 46708-390-31 | Alembic PharmaceuticalsIndia | 1 July 2021 |
| 1000 capsule in 1 bottle | 46708-390-91 | Alembic PharmaceuticalsIndia | 1 July 2021 |
| 100 capsule in 1 bottle | 62332-390-31 | Alembic PharmaceuticalsIndia | 1 July 2021 |
| 1000 capsule in 1 bottle | 62332-390-91 | Alembic PharmaceuticalsIndia | 1 July 2021 |
| 100 capsule in 1 bottle | 68382-559-01 | Zydus LifesciencesIndia | 15 February 2018 |
| 1000 capsule in 1 bottle | 68382-559-10 | Zydus LifesciencesIndia | 15 February 2018 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 68382-559-30 | Zydus LifesciencesIndia | 15 February 2018 |
| 1000 capsule in 1 bottle | 70771-1170-0 | Zydus LifesciencesIndia | 15 February 2018 |
| 100 capsule in 1 bottle | 70771-1170-1 | Zydus LifesciencesIndia | 15 February 2018 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 70771-1170-2 | Zydus LifesciencesIndia | 15 February 2018 |
| 100 capsule in 1 bottle | 59651-753-01 | Aurobindo PharmaIndia | 12 May 2023 |
| 100 capsule in 1 bottle | 70756-411-11 | Lifestar PharmaIndia | 21 March 2023 |
| 100 capsule in 1 bottle | 43386-641-01 | LupinIndia | 9 July 2018 |
| 1000 capsule in 1 bottle | 57664-232-18 | Sun Pharmaceutical IndustriesIndia | 15 April 2016 |
| 100 capsule in 1 bottle | 57664-232-88 | Sun Pharmaceutical IndustriesIndia | 15 April 2016 |
| 100 capsule in 1 bottle | 0115-1643-01 | Amneal Pharmaceuticals of New York | 8 March 2007 |
| 1000 capsule in 1 bottle | 0115-1643-03 | Amneal Pharmaceuticals of New York | 8 March 2007 |
| 100 capsule in 1 bottle | 68001-385-00 | BluePoint Labortories | 14 May 2019 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 60687-839-01 | American Health Packaging | 28 April 2024 |
| 50 blister pack in 1 carton / 1 capsule in 1 blister pack | 60687-839-65 | American Health Packaging | 18 October 2026 |
| 50 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack | 50268-623-15 | AvPAK | 8 December 2017 |
| 100 capsule in 1 bottle | 68001-604-00 | BluePoint Laboratories | 11 October 2023 |
| 28 capsule in 1 bottle | 71335-2254-1 | Bryant Ranch Prepack | 2 October 2023 |
| 40 capsule in 1 bottle | 71335-2254-2 | Bryant Ranch Prepack | 2 October 2023 |
| 20 capsule in 1 bottle | 71335-2254-3 | Bryant Ranch Prepack | 2 October 2023 |
| 90 capsule in 1 bottle | 71335-2254-4 | Bryant Ranch Prepack | 2 October 2023 |
| 30 capsule in 1 bottle | 71335-2254-5 | Bryant Ranch Prepack | 2 October 2023 |
| 12 capsule in 1 bottle | 71335-2254-6 | Bryant Ranch Prepack | 2 October 2023 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 0904-7026-61 | Major Pharmaceuticals | 15 February 2018 |
| 100 capsule in 1 bottle | 72603-183-01 | NorthStar RxLLC | 1 December 2023 |
| 10 capsule in 1 bottle, plastic | 71205-023-10 | Proficient Rx | 2 April 2018 |
| 14 capsule in 1 bottle, plastic | 71205-023-14 | Proficient Rx | 2 April 2018 |
| 20 capsule in 1 bottle, plastic | 71205-023-20 | Proficient Rx | 2 April 2018 |
| 30 capsule in 1 bottle, plastic | 71205-023-30 | Proficient Rx | 26 July 2023 |
| 60 capsule in 1 bottle, plastic | 71205-023-60 | Proficient Rx | 26 July 2023 |
| 90 capsule in 1 bottle, plastic | 71205-023-90 | Proficient Rx | 26 July 2023 |
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
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 50 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.