gamma-Aminobutyric Acid A Receptor Positive Modulator, gamma-Aminobutyric Acid-ergic Agonist
Where is Zolpidem made?
20 companies sell it under their own name and 35 repackagers rebottle it. Their labels name 14 factories in India, the United States and Bangladesh.
India 9United States 4Bangladesh 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Torrent Pharma, Inc.5 mg, 7.5 mg, 10 mg · NDC 13668-008, 13668-007, 13668-775 | Piramal Pharma LimitedMakes it, tests it and packages it | Pithampur, India | No problems foundMay 2023 |
| Torrent Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Indrad, India | Problems found, fixed voluntarilyJun 2024 | |
| Torrent Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Bharuch, India | No problems foundJan 2026 | |
| Umedica Laboratories Private LimitedMakes it, tests it and packages it | Vapi, India | Problems found, fixed voluntarilyMar 2024 | |
| ACI Healthcare USA, Inc.5 mg, 10 mg · NDC 71093-156, 71093-155 | InvaTech Pharma Solutions LLCMakes it, tests it, packages it and labels it | East Brunswick, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| The ACME Laboratories Ltd.Makes it, tests it, packages it and labels it | Dhaka, Bangladesh | Not inspected on record | |
| Aurobindo Pharma Limited5 mg, 10 mg · NDC 65862-160, 65862-159 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Lupin Pharmaceuticals, Inc.1.75 mg, 3.5 mg, 6.25 mg, 12.5 mg · NDC 43386-762, 68180-780, 43386-761 +1 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 | |
| Northstar Rx LLC.5 mg, 10 mg · NDC 16714-622, 16714-621 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Ranbaxy Laboratories Inc.5 mg, 10 mg · NDC 63304-160, 63304-159 | Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 |
| Ranbaxy laboratories Limited ToansaMakes the active ingredient | Location not on file | Not inspected on record | |
| Breckenridge Pharmaceutical, Inc.6.25 mg, 12.5 mg · NDC 51991-982, 51991-981 | Centaur Pharmaceuticals Private LimitedMakes it | Pune, India | Serious problems, FDA actionFeb 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.6.25 mg, 12.5 mg · NDC 47335-308, 47335-307 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| H.J. Harkins Co., Inc.5 mg · NDC 52959-879 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Novel Laboratories, Inc.1.75 mg, 3.5 mg · NDC 40032-762, 40032-761 | Novel Laboratories, Inc.Makes it and tests it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| The ACME Laboratories Ltd.5 mg, 10 mg · NDC 72722-104, 72722-103 | The ACME Laboratories Ltd.Makes it, tests it, packages it and labels it | Dhaka, Bangladesh | Not inspected on record |
| Umedica Laboratories USA Inc.7.5 mg · NDC 60290-089 | Umedica Laboratories Private LimitedMakes it, tests it and packages it | Vapi, India | Problems found, fixed voluntarilyMar 2024 |
| Wockhardt Limited5 mg, 10 mg · NDC 55648-715, 55648-714 | Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Almatica Pharma Inc. zolpidem tartrate7.5 mg · NDC 52427-775 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.5 mg, 10 mg · NDC 62135-779, 62135-778 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cosette Pharmaceuticals, Inc. Ambien, Ambien CR5 mg, 6.25 mg, 10 mg, 12.5 mg · NDC 0713-5421, 0713-5521, 0713-5401 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.1.75 mg, 3.5 mg · NDC 49884-898, 49884-899 | The label doesn't name the factory. Plants this company names for other drugs | ||
| RedPharm Drug Inc.5 mg · NDC 67296-0537 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.5 mg, 6.25 mg, 10 mg, 12.5 mg · NDC 0781-5318, 0781-5316, 0781-5317 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Viatris Specialty LLC Edluar5 mg, 10 mg · NDC 0037-6010, 0037-6050 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Zolpidem in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-5095,50090-5804,50090-3878,50090-6070+6 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0059,80425-0060,80425-0061,80425-0153+6 - Aidarex Pharmaceuticals LLC:
33261-173,33261-172 - American Health Packaging:
60687-838 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-617,71610-152,71610-192,43353-243+14 - Apotheca, Inc.:
12634-944,12634-943 - Asclemed USA, Inc.:
76420-263,76420-417,76420-496,76420-319+4 - Blenheim Pharmacal, Inc.:
10544-539,10544-548,10544-040,10544-540 - Bryant Ranch Prepack:
71335-2303,72162-1983,63629-9614,63629-8999+15 - Calvin Scott & Co., Inc.:
17224-970 - Cardinal Health 107, LLC:
55154-1398 - Direct Rx:
61919-527,61919-803,61919-663,61919-955+4 - Dispensing Solutions Inc.:
66336-718,66336-460 - Golden State Medical Supply, Inc.:
51407-942,51407-762,51407-941,51407-761 - H.J. Harkins Co., Inc.:
52959-880 - Lake Erie Medical DBA Quality Care Products LLC:
55700-357 - Life Line Home Care Services, Inc.:
75921-469 - Major Pharmaceuticals:
0904-6082 - Medsource Pharmaceuticals:
45865-413,45865-956,45865-409 - Northwind Pharmaceuticals:
82868-064,82868-078 - NuCare Pharmaceuticals.Inc.:
68071-2774,68071-3455,68071-5063,68071-5120+9 - PD-Rx Pharmaceuticals, Inc.:
43063-639,72789-323,43063-652,72789-390 - Physicians Total Care, Inc.:
54868-0846,54868-6215,54868-5426,54868-0845+2 - Preferred Pharmaceuticals, Inc..:
68788-9127,68788-8376,68788-7422,68788-9126+3 - Proficient Rx LP:
63187-682,63187-565,71205-691,63187-690+6 - RPK Pharmaceuticals, Inc.:
53002-5020,53002-1292 - Rebel Distributors Corp..:
21695-507,21695-212,21695-213,21695-506+2 - RedPharm Drug Inc.:
67296-0759,67296-0803,67296-0619 - RedPharm Drug. Inc.:
67296-1591 - Remedyrepack Inc.:
70518-3739,70518-3943,70518-2917 - RxChange Co.:
33358-420,33358-439 - St. Mary's Medical Park Pharmacy:
60760-288,60760-819,60760-761,60760-515 - Stat Rx USA:
42549-548,16590-527,16590-010,16590-436+2 - TYA Pharmaceuticals:
64725-0008 - Unit Dose Services:
50436-0008,50436-0007,50436-0009
Recalls
- Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc · 2 recall notices
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.