Data / Drug companies / Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals): 25 companies and 41 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Nitrofurantoin (monohydrate/macrocrystals) is listed in the FDA National Drug Code Directory by 25 companies, with 41 products in commercial distribution. 41 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, and the newest product started marketing on October 19, 2026.
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- Companies listing it
- 25
- Products
- 41
- Generic (ANDA) products
- 41 (100.0%)
- Application numbers
- 5
- Routes
- Oral
- Brand names
- Nitrofurantoin, Nitrofurantoin
- openFDA record search
- api.fda.gov
Companies that list nitrofurantoin (monohydrate/macrocrystals)
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc. | 4 | capsule | Generic drugs (ANDA) | September 14, 2023 |
| A-S Medication Solutions | 3 | capsule | Generic drugs (ANDA) | February 22, 2022 |
| Northwind Health Company, LLC | 3 | capsule | Generic drugs (ANDA) | October 16, 2024 |
| Remedyrepack Inc. | 3 | capsule | Generic drugs (ANDA) | June 16, 2025 |
| Asclemed USA, Inc. | 2 | capsule | Generic drugs (ANDA) | February 22, 2022 |
| Coupler LLC | 2 | capsule | Generic drugs (ANDA) | May 7, 2026 |
| Jubilant Cadista Pharmaceuticals Inc. | 2 | capsule | Generic drugs (ANDA) | February 22, 2022 |
| PD-Rx Pharmaceuticals, Inc. | 2 | capsule | Generic drugs (ANDA) | April 6, 2005 |
| QPharma, Inc. | 2 | capsule | Generic drugs (ANDA) | February 22, 2022 |
| Redpharm Drug | 2 | capsule | Generic drugs (ANDA) | September 14, 2023 |
| St. Mary's Medical Park Pharmacy | 2 | capsule | Generic drugs (ANDA) | October 19, 2026 |
| Aurobindo Pharma Limited | 1 | capsule | Generic drugs (ANDA) | March 30, 2023 |
| BluePoint Laboratories | 1 | capsule | Generic drugs (ANDA) | October 15, 2023 |
| Bryant Ranch Prepack | 1 | capsule | Generic drugs (ANDA) | September 14, 2023 |
| Bryant Ranch Prepack | 1 | capsule | Generic drugs (ANDA) | March 30, 2023 |
| Bryant Ranch Prepack | 1 | capsule | Generic drugs (ANDA) | April 6, 2005 |
| Creekwood Pharmaceuticals LLC | 1 | capsule | Generic drugs (ANDA) | April 20, 2026 |
| Lifestar Pharma LLC | 1 | capsule | Generic drugs (ANDA) | September 14, 2023 |
| Major Pharmaceuticals | 1 | capsule | Generic drugs (ANDA) | April 6, 2026 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 1 | capsule | Generic drugs (ANDA) | February 22, 2022 |
| NorthStar RxLLC | 1 | capsule | Generic drugs (ANDA) | December 1, 2023 |
| Preferred Pharmaceuticals Inc. | 1 | capsule | Generic drugs (ANDA) | January 25, 2024 |
| Proficient Rx LP | 1 | capsule | Generic drugs (ANDA) | April 6, 2005 |
| Proficient Rx LP | 1 | capsule | Generic drugs (ANDA) | September 14, 2023 |
| Sandoz Inc | 1 | capsule | Generic drugs (ANDA) | April 6, 2005 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 41 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 41 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nitrofuran Antibacterial | 41 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.