Drug
Who makes omeprazole?
44 companies list omeprazole as a human prescription drug. Forms: capsule, delayed release; capsule, delayed release pellets; powder, for suspension. 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 omeprazole
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | capsule, delayed release | ANDAANDA075576, ANDA078490, ANDA091352 | 20 | 3 |
| Bryant Ranch PrepackUnited States | capsule, delayed release | ANDAANDA075410, ANDA075576, ANDA075757 | 13 | 1 |
| Proficient Rx LPUnited States | capsule, delayed release | ANDAANDA075410, ANDA075576, ANDA075757 | 13 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | capsule, delayed release; capsule, delayed release pellets | ANDAANDA075410, ANDA076048, ANDA078490 | 11 | 0 |
| NuCare Pharmaceuticals,Inc.United States | capsule, delayed release | ANDAANDA075410, ANDA078490, ANDA091672 | 9 | 1 |
| Golden State Medical Supply Inc.United States | capsule, delayed release; capsule, delayed release pellets | ANDAANDA203481, ANDA212977 | 6 | 1 |
| Dr. Reddy's Laboratories LimitedIndia | capsule, delayed release | ANDAANDA075576, ANDA078490 | 5 | 15 |
| Sandoz Industrial Products S.AAustria | capsule, delayed release | ANDAANDA075757, ANDA076515 | 5 | 5 |
| Northwind Health Company, LLCUnited States | capsule, delayed release | ANDAANDA075576, ANDA075757, ANDA078490 | 5 | 1 |
| Preferred Pharmaceuticals Inc.United States | capsule, delayed release | ANDAANDA075757, ANDA078490, ANDA091672 | 5 | 1 |
| Apotex Inc.Canada | capsule, delayed release | ANDAANDA076048 | 4 | 6 |
| PD-Rx Pharmaceuticals Inc.United States | capsule, delayed release | ANDAANDA075410, ANDA075576, ANDA078490 | 4 | 1 |
| QPharma IncUnited States | capsule, delayed release | ANDAANDA075576, ANDA075757, ANDA203270 | 4 | 1 |
| RemedyRepack, IncUnited States | capsule, delayed release | ANDAANDA078490, ANDA091672, ANDA212977 | 4 | 1 |
| St. Mary's Medical Park PharmacyUnited States | capsule, delayed release | ANDAANDA075576, ANDA075757, ANDA078490 | 4 | 1 |
| Advanced Rx of Tennessee, LLC | capsule, delayed release | ANDAANDA075576, ANDA078490, ANDA091672 | 4 | 0 |
| Northstar Rx, LLC, | capsule, delayed release | ANDAANDA075576, ANDA078490 | 4 | 0 |
| Zydus Lifesciences LimitedIndia | capsule, delayed release | ANDAANDA091352 | 3 | 12 |
| Glenmark Pharmaceuticals Inc., USAIndia | capsule, delayed release | ANDAANDA091672 | 3 | 9 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | capsule, delayed release | ANDAANDA091672 | 3 | 1 |
| HAWAII REPACK INCUnited States | capsule, delayed release | ANDAANDA091672 | 3 | 1 |
| Lannett Company, LLCUnited States | capsule, delayed release | ANDAANDA075410 | 3 | 1 |
| Rising Pharma Holdings, Inc.United States | capsule, delayed release | ANDAANDA203270 | 3 | 1 |
| Xiromed LLCIndia | capsule, delayed release | ANDAANDA212977 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule, delayed release | ANDAANDA091352 | 3 | 1 |
| Quallent Pharmaceuticals Health, LLC | capsule, delayed release | ANDAANDA075576, ANDA078490 | 3 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule, delayed release | ANDAANDA078490 | 2 | 5 |
| Strides Pharma Science LimitedIndia | powder, for suspension | ANDAANDA079182 | 2 | 5 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | capsule, delayed release | ANDAANDA078490, ANDA091672 | 2 | 1 |
| Camber Pharmaceuticals, Inc.United States | capsule, delayed release | ANDAANDA204012 | 2 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | capsule, delayed release | ANDAANDA091672, ANDA212977 | 2 | 1 |
| PHOENIX RX LLCUnited States | capsule, delayed release | ANDAANDA078490, ANDA091672 | 2 | 1 |
| Chartwell RX, LLC. | capsule, delayed release | ANDAANDA075410, ANDA075757 | 2 | 0 |
| Cardinal Health 418, Inc.United States | capsule, delayed release | ANDAANDA091352 | 1 | 34 |
| Aurobindo Pharma LimitedIndia | capsule, delayed release | ANDAANDA203270 | 1 | 6 |
| Boswell Pharmacy Services LLCUnited States | capsule, delayed release | ANDAANDA212977 | 1 | 1 |
| Coupler LLCUnited States | capsule, delayed release | ANDAANDA078490 | 1 | 1 |
| RedPharm DrugUnited States | capsule, delayed release | ANDAANDA078490 | 1 | 1 |
| Unit Dose Solutions, Inc.United States | capsule, delayed release | ANDAANDA091672 | 1 | 1 |
| AvPAK | capsule, delayed release | ANDAANDA078490 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule, delayed release | ANDAANDA091352 | 1 | 0 |
| NuCarePharmaceuticals, Inc. | capsule, delayed release | ANDAANDA091672 | 1 | 0 |
| Preferred Phharmaceuticals Inc. | capsule, delayed release | ANDAANDA203270 | 1 | 0 |
| Quality Care Products, LLC | capsule, delayed release | ANDAANDA075576 | 1 | 0 |
Bulk ingredient listings
- MEDISCA Inc.United States · 3 NDC
- Dr. Reddy's Laboratories LimitedIndia · 2 NDC
- Hetero Drugs LimitedIndia · 2 NDC
- Alivus Life Sciences Limited · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Chromo Laboratories India Private LimitedIndia · 1 NDC
- DISHMAN CARBOGEN AMCIS LIMITEDIndia · 1 NDC
- Dr. Reddys Laboratories Limited · 1 NDC
- EVEREST ORGANICS LIMITEDIndia · 1 NDC
- Granules Pharmaceuticals Inc.India · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- LARSON PHARMA PRIVATE LIMITEDIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- NATCO PHARMA LIMITEDIndia · 1 NDC
- PLD Acquisitions LLC DBA Avma Pharma Solutions · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- QUIMICA SINTETICA SASpain · 1 NDC
- SRINI PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Shouguang Fukang Pharmaceutical Co LtdChina · 1 NDC
- Smilax Laboratories LimitedIndia · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- TAPI Croatia industries d.o.o.Croatia · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
- Yung Shin Pharmaceutical Ind. Co., Ltd. · 1 NDC
- Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.China · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
3 unexpired patents list omeprazole as the active ingredient, expiring between Jan 2030 and Dec 2036. Application holder: DEXCEL PHARMA TECHNOLOGIES LTD.
Enquiry
Common questions
- Who makes omeprazole?
- 44 companies list omeprazole as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Bryant Ranch Prepack, Proficient Rx LP, Aphena Pharma Solutions - Tennessee, LLC, NuCare Pharmaceuticals,Inc.. 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 omeprazole?
- 44 companies list omeprazole under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies omeprazole active ingredient?
- 29 companies list omeprazole as a bulk ingredient, including MEDISCA Inc., Dr. Reddy's Laboratories Limited, Hetero Drugs Limited, Alivus Life Sciences Limited.