Drug
Who makes esomeprazole magnesium?
39 companies list esomeprazole magnesium as a human prescription drug, including under the names NEXIUM. Forms: capsule, delayed release; capsule, delayed release pellets; for suspension; granule, delayed release; granule, for suspension, extended release. Routes: oral.
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 esomeprazole magnesium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | capsule, delayed release; capsule, delayed release pellets | ANDAANDA078279, ANDA205606, ANDA209495 | 11 | 3 |
| Bryant Ranch PrepackUnited States | capsule, delayed release; capsule, delayed release pellets | ANDAANDA205563, ANDA205606, ANDA206296 | 11 | 1 |
| AstraZeneca PLCUnited States | capsule, delayed release; granule, delayed release | NDANDA021153, NDA021957, NDA022101 | 7 | 15 |
| Aurobindo Pharma LimitedIndia | capsule, delayed release; granule, delayed release | ANDAANDA205606, ANDA218948, ANDA219213 | 6 | 6 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | for suspension; granule, for suspension, extended release | ANDAANDA211751, ANDA211752, ANDA217714 | 5 | 7 |
| Torrent Pharma, Inc.India | granule, delayed release | ANDAANDA212651, ANDA212652 | 5 | 5 |
| Zydus Lifesciences LimitedIndia | capsule, delayed release; granule, delayed release | ANDAANDA206055, ANDA206296 | 4 | 12 |
| Preferred Pharmaceuticals Inc.United States | capsule, delayed release | ANDAANDA078279, ANDA212949, ANDA213486 | 4 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule, delayed release; granule, delayed release | ANDAANDA206055, ANDA206296 | 4 | 1 |
| NuCare Pharmaceuticals,Inc.United States | capsule, delayed release | ANDAANDA078279, ANDA213486 | 3 | 1 |
| Proficient Rx LPUnited States | capsule, delayed release | ANDAANDA078279, ANDA213486 | 3 | 1 |
| Advanced Rx of Tennessee, LLC | capsule, delayed release | ANDAANDA211977, ANDA217427 | 3 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | capsule, delayed release | ANDAANDA078279 | 2 | 15 |
| Sun Pharmaceutical Industries LimitedIndia | capsule, delayed release | ANDAANDA209735 | 2 | 13 |
| Biocon Biologics LimitedIndia | capsule, delayed release | ANDAANDA213486 | 2 | 9 |
| Glenmark Pharmaceuticals Inc., USAIndia | capsule, delayed release pellets | ANDAANDA209495 | 2 | 9 |
| Granules Pharmaceuticals Inc.India | capsule, delayed release | ANDAANDA217427 | 2 | 8 |
| Zhejiang Yongtai Pharmaceutical Co., Ltd.China | capsule, delayed release | ANDAANDA217022 | 2 | 2 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | capsule, delayed release | ANDAANDA205606, ANDA211977 | 2 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | capsule, delayed release | ANDAANDA211977 | 2 | 1 |
| Camber Pharmaceuticals, Inc.United States | capsule, delayed release | ANDAANDA211977 | 2 | 1 |
| Golden State Medical Supply Inc.United States | capsule, delayed release | ANDAANDA209735 | 2 | 1 |
| Lannett Company, LLCUnited States | capsule, delayed release pellets | ANDAANDA205563 | 2 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | capsule, delayed release | ANDAANDA078279, ANDA205606 | 2 | 1 |
| RemedyRepack, IncUnited States | capsule, delayed release | ANDAANDA211977, ANDA213486 | 2 | 1 |
| Rising Pharma Holdings, Inc.United States | capsule, delayed release | ANDAANDA212949 | 2 | 1 |
| Somerset Therapeutics Private LimitedIndia | capsule, delayed release | ANDAANDA213859 | 2 | 1 |
| ASCEND Therapeutics US, LLC | capsule, delayed release | ANDAANDA208333 | 2 | 0 |
| Mylan Pharmaceuticals, Inc. | capsule, delayed release pellets | ANDAANDA078936 | 2 | 0 |
| Northstar Rx, LLC, | capsule, delayed release | ANDAANDA078279 | 2 | 0 |
| Quallent Pharmaceuticals Health, LLC | capsule, delayed release | ANDAANDA213486 | 2 | 0 |
| Solco healthcare U.S., LLC | capsule, delayed release | ANDAANDA214920 | 2 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule, delayed release | ANDAANDA211977 | 1 | 5 |
| Direct RxUnited States | capsule, delayed release | ANDAANDA211977 | 1 | 1 |
| MedSource LabsUnited States | capsule, delayed release | ANDAANDA078279 | 1 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | capsule, delayed release | ANDAANDA205606 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | capsule, delayed release | ANDAANDA211977 | 1 | 1 |
| AvPAK | capsule, delayed release | ANDAANDA078279 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule, delayed release | ANDAANDA078279 | 1 | 0 |
Bulk ingredient listings
- Hetero Drugs LimitedIndia · 3 NDC
- Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- MINAKEM Dunkerque ProductionFrance · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- Shouguang Fukang Pharmaceutical Co LtdChina · 1 NDC
- Smilax Laboratories LimitedIndia · 1 NDC
- Vasudha Pharma Chem LimitedIndia · 1 NDC
Orange Book patents
2 unexpired patents list esomeprazole magnesium as the active ingredient, expiring between Dec 2036 and Dec 2036. Application holder: DEXCEL PHARMA TECHNOLOGIES LTD.
Enquiry
Common questions
- Who makes esomeprazole magnesium?
- 39 companies list esomeprazole magnesium as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Bryant Ranch Prepack, AstraZeneca PLC, Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED. 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 NEXIUM?
- 38 companies list esomeprazole magnesium under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies esomeprazole magnesium active ingredient?
- 11 companies list esomeprazole magnesium as a bulk ingredient, including Hetero Drugs Limited, Aurore Pharmaceuticals Private Limited, CIPLA PHARMACEUTICALS LIMITED, Dr. Reddy's Laboratories Limited.