Drug
Who makes zolpidem tartrate?
36 companies list zolpidem tartrate as a human prescription drug, including under the names Ambien, Ambien CR, Edluar. Forms: capsule; tablet; tablet, coated; tablet, extended release; tablet, film coated; tablet, film coated, extended release. Routes: oral, sublingual.
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 zolpidem tartrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet; tablet, coated; tablet, extended release; tablet, film coated, extended release | ANDAANDA077214, ANDA077322, ANDA077903 | 19 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet; tablet, extended release; tablet, film coated; tablet, film coated, extended release | ANDA, NDA AUTHORIZED GENERICANDA077214, ANDA078413, ANDA078970 | 14 | 0 |
| Proficient Rx LPUnited States | tablet; tablet, coated; tablet, extended release; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA076410, ANDA077214, ANDA077322 | 10 | 1 |
| International Medication Systems, Ltd.United States | tablet; tablet, film coated | ANDAANDA077903, ANDA078413 | 9 | 3 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet; tablet, extended release; tablet, film coated | ANDAANDA077903, ANDA078413, ANDA078970 | 8 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet; tablet, extended release; tablet, film coated | ANDAANDA077903, ANDA078413, ANDA078970 | 8 | 1 |
| Golden State Medical Supply Inc.United States | tablet; tablet, coated; tablet, film coated | ANDA, NDAANDA077214, NDA021774 | 6 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet; tablet, coated; tablet, extended release; tablet, film coated, extended release | ANDAANDA077322, ANDA077903, ANDA078970 | 6 | 1 |
| Advanced Rx of Tennessee, LLC | tablet; tablet, coated; tablet, film coated | ANDAANDA077214, ANDA077322, ANDA077903 | 6 | 0 |
| Lupin LimitedIndia | tablet; tablet, extended release | ANDAANDA078970, ANDA204299 | 4 | 14 |
| Sandoz Industrial Products S.AAustria | tablet, coated; tablet, extended release | ANDAANDA077322, ANDA090107 | 4 | 5 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet; tablet, film coated | ANDAANDA077903, ANDA078413 | 4 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet; tablet, coated; tablet, extended release | ANDAANDA077322, ANDA077903, ANDA078970 | 4 | 1 |
| Cosette Pharmaceuticals, Inc. | tablet, coated; tablet, film coated | NDANDA019908, NDA021774 | 4 | 0 |
| Torrent Pharma, Inc.India | capsule; tablet | ANDAANDA077903, ANDA220717 | 3 | 5 |
| RemedyRepack, IncUnited States | tablet; tablet, coated; tablet, film coated | ANDAANDA077322, ANDA077903, ANDA078413 | 3 | 1 |
| Viatris Inc.India | tablet | NDANDA021997 | 2 | 18 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated, extended release | ANDAANDA204170 | 2 | 13 |
| ACI Healthcare USA, Inc.United States | tablet | ANDAANDA077214 | 2 | 2 |
| Direct RxUnited States | tablet; tablet, extended release | ANDAANDA077903, ANDA078970 | 2 | 1 |
| Northwind Health Company, LLCUnited States | tablet; tablet, coated | ANDAANDA077322, ANDA077903 | 2 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA078413 | 2 | 1 |
| The ACME Laboratories Ltd.Bangladesh | tablet, film coated | ANDAANDA077214 | 2 | 1 |
| Breckenridge Pharmaceutical, Inc. | tablet, extended release | ANDAANDA213592 | 2 | 0 |
| Chartwell RX, LLC. | tablet | ANDAANDA077388 | 2 | 0 |
| Northstar Rx, LLC, | tablet, film coated | ANDAANDA078413 | 2 | 0 |
| sanofi-aventis U.S. LLC | tablet, film coated | NDANDA019908 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA077903 | 1 | 34 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA078413 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA078413 | 1 | 5 |
| Calvin Scott & Co., Inc.United States | tablet | ANDAANDA077903 | 1 | 1 |
| UMEDICA LABORATORIES PRIVATE LIMITEDIndia | capsule | ANDAANDA220717 | 1 | 1 |
| Almatica Pharma Inc. | capsule | NDANDA215721 | 1 | 0 |
| DirectRx | tablet | ANDAANDA077903 | 1 | 0 |
| Lake Erie Medical DBA Quality Care Products LLC | tablet | ANDAANDA077903 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA077903 | 1 | 0 |
Bulk ingredient listings
- Alivus Life Sciences Limited · 2 NDC
- AARTI DRUGS LIMITEDIndia · 1 NDC
- Assia Chemical Industries Ltd. - Teva Tech SiteIsrael · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CAMBREX PROFARMACO MILANO SRLItaly · 1 NDC
- CZECH-GEN, a.s.Czechia · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Teva API India Private Ltd.India · 1 NDC
- UQUIFA Mexico, S.A. de C.V. · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
Orange Book patents
5 unexpired patents list zolpidem tartrate as the active ingredient, expiring between Apr 2027 and Aug 2032. Application holders: AYTU BIOSCIENCE INC, PURDUE PHARMA PRODUCTS LP, VIATRIS SPECIALTY LLC.
Enquiry
Common questions
- Who makes zolpidem tartrate?
- 36 companies list zolpidem tartrate as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, Proficient Rx LP, International Medication Systems, Ltd., ASCLEMED USA INC. DBA ENOVACHEM. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Ambien?
- 32 companies list zolpidem tartrate under an abbreviated new drug application (ANDA), the application type used for generics, and 5 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies zolpidem tartrate active ingredient?
- 11 companies list zolpidem tartrate as a bulk ingredient, including Alivus Life Sciences Limited, AARTI DRUGS LIMITED, Assia Chemical Industries Ltd. - Teva Tech Site, Aurobindo Pharma Limited.