Phenothiazine
Where is Promethazine made?
22 companies sell it under their own name and 45 repackagers rebottle it. Their labels name 13 factories in the United States, India, Portugal and Canada.
United States 7India 4Portugal 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals12.5 mg, 25 mg, 50 mg · NDC 65162-745, 53746-745, 65162-521 +3 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Cadila Healthcare Limited12.5 mg, 25 mg, 50 mg · NDC 65841-040, 65841-041, 65841-042 | 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 | |
| Hikma Pharmaceuticals USA Inc.25 mg per 1 mL, 50 mg per 1 mL · NDC 0641-0955, 0641-6208, 0641-6084 +10 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Hikma Pharmaceuticals USA Inc.Makes it, tests it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 | |
| Zydus Pharmaceuticals (USA) Inc.12.5 mg, 25 mg, 50 mg · NDC 68382-040, 68382-041, 68382-042 | 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 | |
| Akorn6.25 mg per 5 mL · NDC 50383-801 | AkornMakes it | Location not on file | Not inspected on record |
| BluePoint Laboratories.12.5 mg, 25 mg, 50 mg · NDC 68001-161, 68001-162, 68001-163 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Camber Pharmaceuticals Inc.12.5 mg, 25 mg · NDC 31722-040, 31722-041 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Cosette Pharmaceuticals, Inc.12.5 mg, 25 mg, 50 mg · NDC 0713-0536, 0713-0526, 0713-0132 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| KVK-TECH, Inc.12.5 mg, 25 mg, 50 mg · NDC 10702-002, 10702-003, 10702-004 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Nostrum Laboratories, Inc.6.25 mg per 5 mL · NDC 29033-500 | Nostrum Laboratories, Inc.Makes it, tests it and packages it | Bryan, Ohio, United States | Problems found, fixed voluntarilyMar 2025 |
| Quagen Pharmaceuticals LLC6.25 mg per 5 mL · NDC 70752-138 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Taro Pharmaceuticals U.S.A., Inc.12.5 mg, 25 mg · NDC 51672-5296, 51672-5297 | Cosette Pharmaceuticals, Inc.Makes it | South Plainfield, New Jersey, United States | No problems foundNov 2024 |
| Xttrium Laboratories, Inc.6.25 mg per 5 mL · NDC 0116-4023 | Halo Pharmaceutical Canada, IncMakes it, tests it, packages it and labels it | Mirabel, Canada | No problems foundFeb 2023 |
| Actavis Pharma, Inc.25 mg, 50 mg · NDC 0591-5307, 0591-5319 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cantrell Drug Company0.5 mg per 1 mL, 0.625 mg per 1 mL · NDC 52533-177, 52533-204 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.6.25 mg per 5 mL · NDC 68999-774 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.6.25 mg per 5 mL · NDC 62135-774 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cranbury Pharmaceuticals, LLC6.25 mg per 5 mL · NDC 27808-051 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.25 mg · NDC 10135-495 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd12.5 mg, 25 mg · NDC 45802-758, 45802-759 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.6.25 mg per 5 mL · NDC 0121-1854 | The label doesn't name the factory. Plants this company names for other drugs | ||
| XGen Pharmaceuticals DJB, Inc.25 mg per 1 mL, 50 mg per 1 mL · NDC 39822-5525, 39822-5550 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Promethazine 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:
50090-3897,50090-3588,50090-2986,50090-6216+17 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0265 - Aidarex Pharmaceuticals LLC:
33261-865,53217-275,33261-131 - American Health Packaging:
60687-660,68084-155 - Apotheca, Inc.:
12634-418 - Asclemed USA, Inc.:
76420-678,76420-388,87063-014,76420-679+4 - Atlantic Biologicals Corps.:
17856-0608,17856-0059,17856-4023 - Blenheim Pharmacal, Inc.:
10544-051,10544-512,10544-618,10544-941 - Bryant Ranch Prepack:
63629-1591,71335-0989,71335-1139,71335-1359+2 - Cardinal Health 107, LLC:
55154-3373,55154-2861 - Carilion Materials Management:
68151-1584,68151-0146 - Coupler Enterprises Inc.:
67046-374 - Coupler LLC:
67046-1069,67046-1043,67046-1447 - Direct Rx:
61919-047,72189-402,61919-008,61919-630+3 - Dispensing Solutions Inc.:
66336-085,68258-3028,55045-1643 - H.J. Harkins Co., Inc.:
52959-731,52959-534 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1247,51662-1248 - Henry Schein, Inc.:
0404-9940,0404-9941,0404-9942 - Kesin Pharma Corporation:
81033-016 - Liberty Pharmaceuticals, Inc.:
0440-8195,0440-5195 - Life Line Home Care Services, Inc.:
75921-438 - Major Pharmaceuticals:
0904-7304 - MedVantx, Inc.:
66116-605 - Medical Purchasing Solutions, LLC.:
71872-7285,71872-7077 - Medsource Pharmaceuticals:
45865-592 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8154 - Northwind Pharmaceuticals:
51655-085,51655-140,51655-758,51655-462+1 - NuCare Pharmaceuticals.Inc.:
68071-4686,68071-4865,68071-4809,68071-4544+2 - PD-Rx Pharmaceuticals, Inc.:
43063-875,55289-928,43063-060,43063-874+3 - PharmPak, Inc.:
54348-117 - Physicians Total Care, Inc.:
54868-4794,54868-5121,54868-0601,54868-1323+6 - Preferred Pharmaceuticals, Inc..:
68788-9270,68788-7886 - ProPharma Distribution:
84549-525,84549-928 - Proficient Rx LP:
63187-949,63187-829,71205-126,71205-658+1 - RPK Pharmaceuticals, Inc.:
53002-4020,53002-4021 - ReadyMeds:
64205-745,64205-521 - Rebel Distributors Corp..:
21695-589,21695-453,21695-649,21695-959+3 - RedPharm Drug. Inc.:
67296-0086,67296-1120,67296-0198,67296-0564 - Remedyrepack Inc.:
70518-2488,70518-4419,70518-1306 - Sportpharm LLC:
85766-108,85766-109,85766-110 - Stat Rx USA:
16590-047,42549-543,16590-191 - State of Florida DOH Central Pharmacy:
53808-0545,53808-0546 - TYA Pharmaceuticals:
64725-0041,64725-5307 - Unit Dose Services:
50436-0521 - Unit Dose Solutions, Inc.:
87441-070
Recalls
- May 8, 2014 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.