Data / Drug companies / Midazolam
Midazolam: 6 companies and 25 products in the FDA NDC directory
Midazolam is listed in the FDA National Drug Code Directory by 6 companies, with 25 products in commercial distribution. 22 of the products (88.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; injection, solution; spray, and the newest product started marketing on June 26, 2025.
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- Companies listing it
- 6
- Products
- 25
- Generic (ANDA) products
- 22 (88.0%)
- Application numbers
- 6
- Controlled substance schedule
- Schedule IV
- Routes
- Intravenous, Intramuscular, Nasal
- Brand names
- Nayzilam
- openFDA record search
- api.fda.gov
Companies that list midazolam
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 14 | injection | Generic drugs (ANDA) | March 29, 2024 |
| Henry Schein, Inc. | 4 | injection; injection, solution | Generic drugs (ANDA) | June 26, 2025 |
| Civica, Inc. | 2 | injection | Generic drugs (ANDA) | December 10, 2019 |
| Micro Labs Limited | 2 | injection, solution | Generic drugs (ANDA) | January 1, 2024 |
| WG Critical Care, LLC | 2 | injection, solution | New drug applications (NDA) | December 31, 2020 |
| Ucb, Inc. | 1 | spray | New drug applications (NDA) | May 17, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 19 | 76% |
| Injection, solution | 5 | 20% |
| Spray | 1 | 4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 22 | 88% |
| New drug applications (NDA) | 3 | 12% |
Pharmacologic classes
| Class | Products |
|---|---|
| Benzodiazepine | 25 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). 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.