Azole Antifungal
Where is Fluconazole made?
22 companies sell it under their own name and 35 repackagers rebottle it. Their labels name 15 factories in India, the United States, Portugal, Romania, Ireland and China.
India 7United States 4Portugal 1Romania 1Ireland 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories.50 mg, 100 mg, 150 mg, 200 mg · NDC 68001-252, 68001-253, 68001-254 +1 | Alivus Life Sciences LimitedMakes the active ingredient and tests it | Ankleshwar, India | Problems found, fixed voluntarilyJan 2025 |
| Glenmark Pharmaceuticals LimitedMakes it | Goa, India | Problems found, fixed voluntarilyJun 2026 | |
| Cadila Healthcare Limited50 mg, 100 mg, 150 mg, 200 mg · NDC 70771-1064, 70771-1065, 70771-1066 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Zydus Pharmaceuticals (USA) Inc.50 mg, 100 mg, 150 mg, 200 mg · NDC 70710-1138, 70710-1139, 70710-1140 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Aurobindo Pharma Limited10 mg per 1 mL, 40 mg per 1 mL, 50 mg, 100 mg, 150 mg, 200 mg · NDC 65862-299, 65862-059, 65862-060 +3 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Baxter Healthcare Corporation200 mg per 100 mL, 400 mg per 200 mL · NDC 0338-6046, 0338-6045 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Jayuya, PR, United States | Problems found, fixed voluntarilyJul 2024 |
| Chartwell RX, LLC.50 mg, 100 mg, 150 mg, 200 mg · NDC 62135-131, 62135-132, 62135-133 +1 | Chartwell Pharmaceuticals Congers, LLC.Makes it, tests it, packages it and labels it | Congers, NY, United States | Serious problems, FDA actionNov 2025 |
| Dr.Reddy's Laboratories Ltd.50 mg, 100 mg, 150 mg, 200 mg · NDC 55111-144, 55111-145, 55111-146 +1 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Drug Ocean LLC50 mg, 100 mg, 150 mg, 200 mg · NDC 70985-014, 70985-015, 70985-016 +1 | Unique Pharmaceutical LaboratoriesMakes it | Bharuch, India | Problems found, fixed voluntarilyOct 2022 |
| Glenmark Pharmaceuticals Inc., USA50 mg, 100 mg, 150 mg, 200 mg · NDC 68462-102, 68462-103, 68462-119 +2 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Golden State Medical Supply, Inc.150 mg · NDC 51407-426 | Novitium Pharma LLCMakes it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Hikma Pharmaceuticals USA Inc.2 mg per 1 mL · NDC 0143-9899, 0143-9669, 0143-9668 +2 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Hospira, Inc.200 mg per 100 mL, 400 mg per 200 mL · NDC 0409-3435, 0409-4321 | Infomed Fluids SRLMakes it, tests it, packages it, labels it and sterilizes it | Bucuresti, Romania | Problems found, fixed voluntarilyApr 2023 |
| Mylan Pharmaceuticals Inc.10 mg per 1 mL, 40 mg per 1 mL, 50 mg, 100 mg, 150 mg, 200 mg · NDC 59762-5029, 59762-5016, 59762-5017 +3 | Pfizer Ireland Pharmaceuticals Unlimited CompanyMakes the active ingredient and tests it | Ringaskiddy, Ireland | Problems found, fixed voluntarilyOct 2024 |
| Northstar Rx LLC.10 mg per 1 mL, 40 mg per 1 mL, 50 mg, 100 mg, 150 mg, 200 mg · NDC 16714-695, 16714-691, 16714-692 +3 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Radha Pharmaceuticals, Inc.50 mg, 100 mg, 150 mg, 200 mg · NDC 77771-397, 77771-398, 77771-399 +1 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Rising Pharma Holdings, Inc.10 mg per 1 mL, 40 mg per 1 mL, 50 mg, 100 mg, 150 mg, 200 mg · NDC 57237-149, 57237-004, 57237-005 +3 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Roerig Diflucan50 mg, 100 mg, 150 mg, 200 mg, 350 mg per 35 mL, 1400 mg per 35 mL · NDC 0049-3420, 0049-3450, 0049-3500 +3 | Pfizer Ireland Pharmaceuticals Unlimited CompanyMakes the active ingredient and tests it | Ringaskiddy, Ireland | Problems found, fixed voluntarilyOct 2024 |
| Slate Run Pharmaceuticals, LLC.40 mg per 1 mL · NDC 70436-227 | Zhejiang Poly Pharm. Co., LtdMakes it and tests it | Hangzhou, China | Problems found, fixed voluntarilyNov 2024 |
| Zhejiang Poly Pharm. Co., Ltd.40 mg per 1 mL · NDC 72673-091 | Zhejiang Poly Pharm. Co., LtdMakes it, tests it and packages it | Hangzhou, China | Problems found, fixed voluntarilyNov 2024 |
| ANI Pharmaceuticals, Inc.50 mg, 100 mg, 150 mg, 200 mg · NDC 62559-991, 62559-992, 62559-993 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Renaissance SSA, LLC2 mg per 1 mL · NDC 70655-002, 70655-088 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals2 mg per 1 mL · NDC 25021-184 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluconazole 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:
50090-3194,50090-5299,50090-6733,50090-1429+10 - Aidarex Pharmaceuticals LLC:
33261-487,33261-229 - American Health Packaging:
68084-728,68084-735 - Apotheca, Inc.:
12634-780 - Apothecary Shop Wholesale Inc.:
42852-003 - Asclemed USA, Inc.:
87063-204,76420-164,76420-587,87063-205+2 - AvPAK:
50268-337,50268-339 - Avera McKennan Hospital:
69189-5016 - Blenheim Pharmacal, Inc.:
10544-855,10544-610,10544-178 - Bryant Ranch Prepack:
71335-1948,63629-9134,71335-0686,71335-1448+8 - Cardinal Health 107, LLC:
55154-3400,55154-7875 - Central Texas Community Health Centers:
76413-161 - Coupler LLC:
67046-2000,67046-0623,67046-2044,67046-1546 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-935,70934-501,70934-783 - Direct Rx:
61919-419,72189-140,61919-282,72189-143+5 - Dispensing Solutions Inc.:
66336-570,68258-3036,55045-3453 - Golden State Medical Supply, Inc.:
51407-425,51407-427,51407-424 - Hawaii Repack, Inc.:
85534-0049 - Major Pharmaceuticals:
0904-6500,0904-6501 - MedVantx, Inc.:
66116-481,66116-510 - Northwind Pharmaceuticals:
51655-889,51655-435,82868-033 - NuCare Pharmaceuticals.Inc.:
68071-2601,68071-4501,68071-3768,68071-2436+9 - PD-Rx Pharmaceuticals, Inc.:
43063-645,43063-642,55289-824 - Pharmasource Meds, LLC:
82982-070 - Physicians Total Care, Inc.:
54868-5248,54868-5345,54868-5129,54868-5144+1 - Preferred Pharmaceuticals, Inc..:
68788-7293,68788-8526,68788-4163 - Proficient Rx LP:
71205-650,82804-218,71205-081,71205-563+6 - RPK Pharmaceuticals, Inc.:
53002-4400,53002-2198,53002-4198,53002-1198+2 - Rebel Distributors Corp..:
21695-131,21695-193,21695-560 - RedPharm Drug. Inc.:
67296-2077,67296-1498,67296-1627,67296-2274+3 - Remedyrepack Inc.:
70518-2415,70518-4193,70518-3901,70518-4242+6 - Sportpharm LLC:
85766-102,85766-157,85766-167,85766-103+5 - St. Mary's Medical Park Pharmacy:
60760-950,60760-803 - Stat Rx USA:
16590-282,16590-283 - Unit Dose Services:
50436-5128,50436-1139,50436-0103
Recalls
- May 15, 2017 · Class II · Baxter Healthcare Corporation
Lack of assurance of sterility: customer complaints received for the presence of leaks. - Jan 5, 2017 · Class II · The Harvard Drug Group · 2 recall notices
Failed Dissolution Specifications - Dec 28, 2016 · Class II · Dr. Reddy's Laboratories, Inc. · 4 recall notices
Failed Dissolution Specifications; 18 month stability time point - Dec 6, 2016 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. - Dec 23, 2014 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. - Jan 29, 2014 · Class II · Pfizer Inc.
Defective Container: Tamper evident ring failures discovered on some bottles.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.