Data / Drug companies / Zolpidem tartrate
Zolpidem tartrate: 38 companies and 140 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Zolpidem tartrate is listed in the FDA National Drug Code Directory by 38 companies, with 140 products in commercial distribution. 129 of the products (92.1%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; tablet, film coated; tablet, extended release, and the newest product started marketing on June 23, 2026.
The request: Get every company that lists zolpidem tartrate in the FDA NDC directory, with headquarters, website and number of employees. $10 of work on sign-up, no card.
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- Companies listing it
- 38
- Products
- 140
- Generic (ANDA) products
- 129 (92.1%)
- Application numbers
- 16
- Controlled substance schedule
- Schedule IV
- Routes
- Oral, Sublingual
- Brand names
- Zolpidem, Ambien, Edluar, Ambien CR
- openFDA record search
- api.fda.gov
Companies that list zolpidem tartrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 14 | tablet, film coated; tablet, film coated, extended release | Generic drugs (ANDA) | September 24, 2020 |
| Advanced Rx of Tennessee, LLC | 10 | tablet; tablet, film coated | Generic drugs (ANDA) | April 15, 2025 |
| A-S Medication Solutions | 9 | tablet, film coated; tablet | Generic drugs (ANDA) | September 5, 2007 |
| Asclemed USA, Inc. | 8 | tablet, extended release; tablet, film coated | Generic drugs (ANDA) | December 17, 2020 |
| Bryant Ranch Prepack | 8 | tablet; tablet, extended release | Generic drugs (ANDA) | September 24, 2020 |
| Bryant Ranch Prepack | 8 | tablet; tablet, extended release | Generic drugs (ANDA) | September 24, 2020 |
| NuCare Pharmaceuticals,Inc. | 8 | tablet; tablet, extended release | Generic drugs (ANDA) | April 11, 2014 |
| Proficient Rx LP | 8 | tablet; tablet, coated | Generic drugs (ANDA) | October 31, 2011 |
| Preferred Pharmaceuticals Inc. | 6 | tablet, extended release; tablet | Generic drugs (ANDA) | April 11, 2025 |
| Cosette Pharmaceuticals, Inc. | 4 | tablet, film coated; tablet, coated | New drug applications (NDA) | February 7, 2025 |
| Golden State Medical Supply, Inc. | 4 | tablet, coated; tablet, film coated | New drug applications (NDA) | April 23, 2007 |
| Sandoz Inc | 4 | tablet, coated; tablet, extended release | Generic drugs (ANDA) | October 31, 2011 |
| St. Mary's Medical Park Pharmacy | 4 | tablet; tablet, coated | Generic drugs (ANDA) | August 28, 2024 |
| Bryant Ranch Prepack | 3 | tablet; tablet, film coated, extended release | Generic drugs (ANDA) | September 24, 2020 |
| Remedyrepack Inc. | 3 | tablet, film coated; tablet | Generic drugs (ANDA) | December 8, 2023 |
| Torrent Pharmaceuticals Limited | 3 | tablet; capsule | Generic drugs (ANDA) | June 23, 2026 |
| Aci Healthcare USA, Inc. | 2 | tablet | Generic drugs (ANDA) | September 24, 2020 |
| Aurobindo Pharma Limited | 2 | tablet, film coated | Generic drugs (ANDA) | May 4, 2007 |
| Breckenridge Pharmaceutical, Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | May 18, 2026 |
| Chartwell RX, LLC | 2 | tablet | Generic drugs (ANDA) | August 27, 2024 |
| Direct RX | 2 | tablet | Generic drugs (ANDA) | August 19, 2019 |
| Lupin Pharmaceuticals, Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | April 11, 2014 |
| Lupin Pharmaceuticals,Inc. | 2 | tablet | Generic drugs (ANDA) | March 22, 2016 |
| NorthStar Rx LLC | 2 | tablet, film coated | Generic drugs (ANDA) | May 4, 2007 |
| Northwind Health Company, LLC | 2 | tablet, coated; tablet | Generic drugs (ANDA) | May 20, 2025 |
| PD-Rx Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | May 4, 2007 |
| Proficient Rx LP | 2 | tablet, extended release; tablet | Generic drugs (ANDA) | September 24, 2020 |
| Sun Pharmaceutical Industries, Inc. | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | May 15, 2017 |
| The Acme Laboratories Ltd. | 2 | tablet, film coated | Generic drugs (ANDA) | September 24, 2020 |
| Viatris Specialty LLC | 2 | tablet | New drug applications (NDA) | July 24, 2009 |
| Almatica Pharma LLC | 1 | capsule | New drug applications (NDA) | May 9, 2023 |
| American Health Packaging | 1 | tablet, film coated | Generic drugs (ANDA) | September 1, 2024 |
| Calvin Scott & Co., Inc. | 1 | tablet | Generic drugs (ANDA) | September 5, 2007 |
| Cardinal Health 107, LLC | 1 | tablet | Generic drugs (ANDA) | September 5, 2007 |
| Direct_Rx | 1 | tablet, extended release | Generic drugs (ANDA) | June 4, 2021 |
| Major Pharmaceuticals | 1 | tablet | Generic drugs (ANDA) | September 5, 2007 |
| Quality Care Products, LLC | 1 | tablet | Generic drugs (ANDA) | September 5, 2007 |
| Umedica Laboratories USA Inc. | 1 | capsule | Generic drugs (ANDA) | May 14, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 55 | 39.3% |
| Tablet, film coated | 34 | 24.3% |
| Tablet, extended release | 24 | 17.1% |
| Tablet, coated | 15 | 10.7% |
| Tablet, film coated, extended release | 9 | 6.4% |
| Capsule | 3 | 2.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 129 | 92.1% |
| New drug applications (NDA) | 9 | 6.4% |
| Authorized generics (NDA) | 2 | 1.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| gamma-Aminobutyric Acid A Receptor Positive Modulator | 109 |
| gamma-Aminobutyric Acid-ergic Agonist | 31 |
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.