Drug
Who makes nitrofurantoin monohydrate?
2 companies list nitrofurantoin monohydrate as a human prescription drug. Forms: capsule. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing nitrofurantoin monohydrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Direct RxUnited States | capsule | NDANDA020064 | 1 | 1 |
| PharmPak, Inc.United States | capsule | NDANDA020064 | 1 | 1 |
Bulk ingredient listings
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 5 NDC
- Mankind Pharma LimitedIndia · 2 NDC
- ASolution Pharmaceuticals Pvt LtdIndia · 1 NDC
- Arch Pharmalabs LimitedIndia · 1 NDC
- Derivados Quimicos SAUSpain · 1 NDC
- Micro Labs LimitedIndia · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
Enquiry
Common questions
- Who makes nitrofurantoin monohydrate?
- 2 companies list nitrofurantoin monohydrate as a human prescription drug in the openFDA NDC Directory, led by Direct Rx, PharmPak, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies nitrofurantoin monohydrate active ingredient?
- 8 companies list nitrofurantoin monohydrate as a bulk ingredient, including FIS FABBRICA ITALIANA SINTETICI SPA, Mankind Pharma Limited, ASolution Pharmaceuticals Pvt Ltd, Arch Pharmalabs Limited.